Globally, the majority of new HIV infections are in women, underscoring the urgent need for woman-initiated prevention strategies. Women need more options to protect themselves from infection because current prevention strategies are not always feasible for them. During sexual HIV transmission, the virus crosses the genital/rectal/oral surfaces to enter the body and establish infection. An effective microbicide would have the potential to limit infection when applied before or after sexual activity, and would be an important HIV prevention tool. Microbicides are being developed primarily as female-initiated methods to reduce male-to-female transmission of HIV, and possibly other sexually transmitted infections. However, rectal microbicides will be useful for heterosexual couples as well as men who have sex with men. Microbicide products could also deliver or have contraceptive properties offering protection against unwanted pregnancies.
Population Council focus
The Council's comprehensive approach to microbicides development comprises all aspects of research, from the laboratory to the field, product introduction, and public education. Council researchers are developing a next generation of microbicides with new formulations and mechanisms of action, including protection against other sexually transmitted infections and prevention of pregnancy. Complementary research seeks to increase adherence to product use, improve reporting of adherence and sensitive behaviors that have an impact on study outcomes, identify more effective methods for recruiting the most appropriate study populations, and improve the informed consent process.
Current work includes:
- Since 1989, biomedical researchers have been conducting basic science research on the sexual transmission of HIV and screening compounds for potential microbicidal activity. Novel strategies are being tested for their ability to activate mucosal dendritic cells in vitro and in vivo to suppress virus growth while boosting immunity.
- The Council has a current product pipeline that includes next-generation gels based on carrageenan as well as other natural and man-made polymers that contain one or more active pharmaceutical ingredients and can be used independently of coitus as well as rings that remain in place for 1–6 months for long-acting delivery of anti-HIV compounds in the vagina.
Population Council impact
- Using both in vitro and in vivo models, scientists have determined the efficacy of a variety of compounds for activity against HIV and other sexually transmitted pathogens.
- The Council conceived, developed, and advanced through clinical trials its first lead candidate microbicide, Carraguard®, an aqueous gel containing carrageenan (a natural polymer obtained from seaweed). Carraguard was the first microbicide candidate to complete a Phase 3 microbicide efficacy clinical trial among a general population of women as planned and with no safety concerns.
- Studies of whether audio computer-assisted self-interviewing (ACASI) produces more accurate reporting of adherence and higher reporting of sexual behavior than a standard face-to-face interview are contributing to improved clinical trial methods and more accurate reporting of sensitive behaviors.
Future directions
Council staff are investigating new active pharmaceutical ingredients for the next-generation formulations. These include new-generation non-nucleoside reverse transcriptase inhibitors and the natural compound zinc, as well as other novel agents. The Council also plans to explore combined microbicide/contraceptive rings capitalizing on the Council’s progress with contraceptive rings. Council staff also are conducting several additional experimental studies aimed at improving methodology for future clinical trials. In particular, researchers are testing the use of interactive voice response survey (IVRS) systems to improve adherence and reporting of adherence and further developing the Council’s customized ACASI software and exploring its integration with FDA regulatory procedures for electronic records in clinical trials.
A Simulated Clinical Trial to Explore Willingness to Participate and Methods for Improving Reporting of Adherence Among a Sex-worker Cohort in Nellore, India (more)
A simulated microbicides clinical study is being conducted in India to develop and test strategies for improving recruitment, adherence, and the reporting of adherence for future microbicides clinical trials.
(1/2008 - ongoing)
India
A Simulated Microbicide Clinical Trial to Explore Methods for Improving Adherence and Reporting of Adherence Among Women in Lusaka, Zambia (more)
Council researchers are conducting a simulated microbicides clinical study in Zambia to develop and test strategies for improving recruitment, adherence, and the reporting of adherence for future microbicides clinical trials.
(9/2010 - ongoing)
Zambia
Audio Computer-assisted Self-interviewing (ACASI) and Microbicides (more)
Council researchers are using ACASI to conduct behavioral and social science research about microbicides.
(1/2006 - ongoing)
Malawi, South Africa, Uganda, United States, Zambia, Zimbabwe
Fertility Intentions and Reproductive Health Needs of Newly HIV-infected Women (more)
Council researchers conducted a study with women who recently tested HIV-positive to determine their fertility intentions and RH needs.
(1/2008 - ongoing)
South Africa
Household Survey for Recruitment of Participants to a Simulated Microbicide Trial in Lusaka, Zambia (more)
Council researchers in Zambia will assess the feasibility, cost, and effectiveness of a household-based survey to recruit study participants for a simulated microbicide clinical trial.
(1/2010 - ongoing)
Zambia
Nonclinical Laboratory Studies: Microbicide Formulation and Delivery (more)
Population Council laboratory scientists are developing vaginal rings and water-based gels to deliver microbicide formulations.
(1/2004 - ongoing)
United States
Nonclinical Laboratory Studies: PC-1005 Gel (Carrageenan with Added MIV-150 and Zinc Salts) (more)
Council scientists are investigating microbicide gels containing carrageenan, MIV-150, and zinc salts that might block acquisition and transmission of herpes and HIV.
(1/2004 - ongoing)
United States
Nonclinical Laboratory Studies: PC-700 Series Gels (Carrageenan with Zinc Salts) (more)
Council researchers are studying microbicide gels containing carrageenan and zinc salts that might block acquisition and transmission of herpes and HIV.
(1/2000 - ongoing)
United States
Nonclinical Laboratory Studies: Vaginal Rings Loaded with MIV-150 (more)
Council scientists are conducting studies of vaginal rings releasing MIV-150 that might provide continuous protection from acquisition and transmission of HIV for at least one month.
(1/2007 - ongoing)
United States
Evaluation of the Informed Consent Process in the Phase 3 Study of the Candidate Microbicide Carraguard® (more)
Council researchers evaluated the informed consent process in the Council’s Phase 3 trial of the candidate microbicide Carraguard.
(1/2006 - 12/2008)
South Africa
Microbicides Acceptability Research (more)
Council researchers collected data on social, cultural, and sexual norms and practices, and on interpersonal relationships, to better understand their impact on microbicide acceptability and use.
(10/2006 - 12/2007)
South Africa
Evaluating Services for Women Who Tested HIV-positive During the Phase 3 Trial (more)
Council researchers evaluated the referrals for care and support provided to women who tested positive for HIV during the Council’s Phase 3 trial of Carraguard.
(4/2006 - 6/2007)
South Africa
Clinical Studies: Carraguard® Phase 3 Clinical Trial (more)
Council researchers completed Phase 3 testing of the Council’s candidate microbicide Carraguard.
(3/2004 - 3/2007)
South Africa
"Microbicide product research and development," fact sheet (PDF)
Population Council
Publication date: 2010
"The Population Council, HIV and AIDS, and microbicides," fact sheet (PDF) (HTML)
Publication date: 2009
A macaque model to study vaginal HSV-2/immunodeficiency virus co-infection and the impact of HSV-2 on microbicide efficacy (abstract) (HTML)
Crostarosa,Federica; Aravantinou,Meropi; Akpogheneta,Onome J.; Jasny,Edith; Shaw,Andrew; Kenney,Jessica; Piatak Jr.,Michael; Lifson,Jeffrey D.; Teitelbaum,Aaron; Hu,Lieyu; Chudolij,Anne; Zydowsky,Thomas M.; Blanchard,James; Gettie,Agegnehu; Robbiani,Melissa
PLoS ONE 4(11): e8060 (1)-e8060 (14)
Publication date: 2009
Acceptability of a Carrageenan-based candidate vaginal microbicide and matching placebo: Findings from a phase II safety trial among women in Chiang Rai, Thailand (abstract)
Jones,Heidi E.; Chaikummao,Supaporn; van de Wijgert,Janneke; Friedland,Barbara A.; Manopaiboon,Chomnad; Witwatwongwana,Paisit; Wankrairoj,Mayuree; Chantharojwong,Nartlada; Kilmarx,Peter H.
Journal of Women's Health 18(7): 1003-1010
Publication date: 2009
Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard® gel: A randomized, cross-over, pharmacokinetic study (abstract)
Brache,Vivian; Croxatto,Horacio B.; Kumar,Narender; Sitruk-Ware,Regine; Cochon,Leila; Schiappacasse,Veronica; Sivin,Irving; Munoz,Carla; Maguire,Robin A.; Faundes,Anibal
Contraception 79(2): 150-154
Publication date: 2009
Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews (abstract)
Turner,Abigail Norris; de Kock,Alana; Meehan-Ritter,Amy; Blanchard,Kelly; Sebola,Mohlatlego H.; Hoosen,Anwar; Coetzee,Nicol; Ellertson,Charlotte
Journal of Clinical Epidemiology 62(7): 759-765
Publication date: 2009
Trial showed anti-HIV microbicide candidate is safe, but did not prove it effective (PDF)
Population Briefs 15(1)
Publication date: 2009
Use of computer-assisted self-interview to assess product use in microbicide trials: Lessons learned in HPTN 035 (PDF)
poster presentation at the 18th International Society for Sexually Transmitted Diseases Research (ISSTDR), London, 28 June-1 July
McVarish,L.; Gorbach,P.; Mensch,Barbara S.; Coly,A.; Young,A.; Masse,Benoit R.; Makanani,B.; Chinula,L.; Nkhoma,C.; Tembo,T.; Mierzwa,Stan; Reynolds,K.; Hurst,S.; Coletti,Anne S.; Forsyth,A.
Publication date: 2009
Vaginal microbicide adherence biomarkers should be validated--Authors' reply
Skoler-Karpoff,Stephanie; Friedland,Barbara A.; Plagianos,Marlena Gehret; Maguire,Robin A.; Lahteenmaki,Pekka
Lancet 373(9665): 721-722
Publication date: 2009
Candida albicans-induced DC activation reduces HIV amplification by DCs while increasing DC-to-T-cell spread of HIV (abstract)
Vachot,Laurence; Williams,Vennansha G.; Bess Jr.,Julian W.; Lifson,Jeffrey D.; Robbiani,Melissa
Journal of Acquired Immune Deficiency Syndromes 48(4): 398-407
Publication date: 2008
A comparison between self-reported condom use and presence of spermatozoa using TV Inpouch and wet mount, among women enrolled in the Phase 3 Carraguard® clinical trial in Cape Town (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Gopolang,F.P.; Gehret,Marlena; Altini,Lydia
Publication date: 2008
A randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand (abstract)
Kilmarx,Peter H.; Blanchard,Kelly; Chaikummao,Supaporn; Friedland,Barbara A.; Srivirojana,Nucharee; Connolly,Cathy; Witwatwongwana,Paisit; Supawitkul,Somsak; Mock,Philip A.; Chaowanachan,Thanyanan; Tappero,Jordan W.
Sexually Transmitted Diseases 35(3): 226-232
Publication date: 2008
Acceptability of Carraguard® vaginal gel among HIV-infected women-Results from a randomized, controlled, crossover trial, Thailand (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Whitehead,Sara J.; McLean,C.M.; Chaikummao,Supaporn; Braunstein,Sarah; Utaivoravit,W.; van de Wijgert,Janneke; Siraprapasiri,Taweesap; Markowitz,Lauri
Publication date: 2008
Acceptability of the vaginal microbicide Carraguard® among couples in Chiang Rai, Thailand (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Martin,Sarah; Blanchard,Kelly; Manopaiboon,Chomnad; Chaikummao,Supaporn; Schaffer,Kate; Friedland,Barbara A.; Kilmarx,Peter H.
Publication date: 2008
An analysis of varying measures of adherence among women enrolled in the Carraguard® Phase 3 trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Littlefield,Sarah A.; Gehret,Marlena; Friedland,Barbara A.; Maguire,Robin A.; Govender,Sumentheran N.; Vilakazi,Hlengiwe; Carolus,N.; Rossier,Jasmine; Sibanyoni,F.; Modise,J.; Palanee,Thesla; Ramjee,Gita; de Kock,Alana; Ahmed,Khatija
Publication date: 2008
An evaluation of care and support of women who test HIV positive during the Phase 3 Carraguard® trial in South Africa (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Harries,Jane; Patel,Smruti; Cassim,Nazira; Friedland,Barbara A.; Ahmed,Khatija; Mtimkulu,Vuyelwa; Palanee,Thesla; Morar,Neetha S.; Milford,C.
Publication date: 2008
Assessing the reporting of adherence and sexual activity in a simulated microbicide trial: Preliminary results from an interview mode experiment in the Phase 3 Carraguard® sites, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Mensch,Barbara S.; Hewett,Paul C.; Rankin,Johanna; Littlefield,Sarah A.; Abbott,Sharon; Ahmed,Khatija; Cassim,Nazira; Patel,Smruti; Mehlomakulu,Vuyelwa; Ramjee,Gita; Palanee,Thesla; Skoler,Stephanie; Gehret,Marlena; Govender,Sumentheran N.
Publication date: 2008
Challenges and results of including 16-17-year-old women in the Carraguard® Phase 3 efficacy trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Skoler,Stephanie; Friedland,Barbara A.; Gehret,Marlena; Ngcozela,N.; Mthembu,P.N.; Palanee,Thesla; de Kock,Alana; Ahmed,Khatija; Malebo Ratlhagana,Mary-Jane
Publication date: 2008
Community misunderstandings arising from premature closure of cellulose sulfate trial and scheduled completion of Carraguard trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Mthembu,P.N.; Palanee,Thesla; Ramjee,Gita
Publication date: 2008
Consentement éclairé dans les essais de prévention du VIH: Points saillants d'un atelier international [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Consentimento informado nos ensaios de prevenção do HIV: Pontos altos dum workshop internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Consentimiento informado en ensayos de prevención del VIH: Aspectos destacados de un taller internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Decision making and the influences of others in the informed consent process: A qualitative investigation in the Phase 3 study of Carraguard® (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Abbott,Sharon; Friedland,Barbara A.; Katzen,Lauren; de Kock,Alana; Madiba,Sphiwe; Cishe,Sheila
Publication date: 2008
Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials (abstract)
van de Wijgert,Janneke; Kilmarx,Peter H.; Jones,Heidi E.; Karon,John M.; Chaikummao,Supaporn
Contraception 77(2): 122-129
Publication date: 2008
Efficacy of Carraguard for prevention of HIV infection in women in South Africa: A randomised, double-blind, placebo-controlled trial (abstract)
Skoler-Karpoff,Stephanie; Ramjee,Gita; Ahmed,Khatija; Altini,Lydia; Gehret,Marlena; Friedland,Barbara A.; Govender,Sumentheran N.; de Kock,Alana; Cassim,Nazira; Palanee,Thesla; Dozier,Gregory; Maguire,Robin A.; Lahteenmaki,Pekka
Lancet 372(9654): 1977-1987
Publication date: 2008
Efficacy of Carraguard-based microbicides in vivo despite variable in vitro activity (abstract) (PDF)
Turville,Stuart G.; Aravantinou,Meropi; Miller,Todd; Kenney,Jessica; Teitelbaum,Aaron; Hu,Lieyu; Chudolij,Anne; Zydowsky,Thomas M.; Piatak Jr.,Michael; Bess Jr.,Julian W.; Lifson,Jeffrey D.; Blanchard,James; Gettie,Agegnehu; Robbiani,Melissa
PLoS ONE 3(9): e3162-
Publication date: 2008
Ensuring care through adequate referrals and community partnerships for women participating in HIV prevention trials: Experience from the Phase 3 Carraguard® trial in Isipingo, KwaZulu Natal, Durban, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Ramjee,Gita
Publication date: 2008
Establishing the standard of care in HIV prevention trials: Experience of Setshaba Research Centre (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Ahmed,Khatija
Publication date: 2008
Evaluation of a video to enhance the informed consent process in the Phase 3 Carraguard® trial (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Friedland,Barbara A.; Skoler,Stephanie; de Kock,Alana; Katzen,Lauren; Apicella,Louis; Williams,Manuela M.; Mehlomakulu,Vuyelwa; Mtimkulu,Vuyelwa
Publication date: 2008
Idhini fahamishi katika majaribio ya kikliniki ya ukingaji wa virusi vya ukimwi [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Impact of acceptability on adherence in the Carraguard® Phase 3 trial (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Friedland,Barbara A.; Littlefield,Sarah A.; Skoler,Stephanie; de Kock,Alana; Palanee,Thesla; Gehret,Marlena; Katzen,Lauren; Morar,Neetha S.; Mehlomakulu,Vuyelwa; Williams,Manuela M.
Publication date: 2008
Impact of provision of hormonal contraception on pregnancy incidence in women enrolled in the Phase 3 Carraguard® clinical trial at three sites in South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Cele,N.; Palanee,Thesla; Myeni,N.; Mnyandu,N.; Langa,Z.; Shange,E.; Gehret,Marlena; Lahteenmaki,Pekka; Skoler,Stephanie; Altini,Lydia; Patel,Smruti; Ahmed,Khatija; Cassim,Nazira; Ramjee,Gita
Publication date: 2008
Imvume unolwazi ocwaningweni lokuvimbela igciwane lesandulela ngculaza [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Incidence and point prevalence of sexually transmitted and reproductive tract infections among women enrolled in the Phase 3 Carraguard® trial in South Africa (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Gehret,Marlena; Skoler,Stephanie; Lahteenmaki,Pekka; Friedland,Barbara A.; Patel,Smruti; Ahmed,Khatija; Cassim,Nazira; Altini,Lydia; Morar,Neetha S.; Govender,Sumentheran N.; Zhou,Lifen; Ramjee,Gita
Publication date: 2008
Informed consent in HIV prevention trials: Highlights from an international workshop (PDF)
Publication date: 2008
Male partner circumcision and HIV seroconversion among participants in the Phase 3 Carraguard® microbicide trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Gehret,Marlena; Palanee,Thesla; Skhosana,Joseph; Friedland,Barbara A.; Littlefield,Sarah A.; de Kock,Alana; Williams,Nela; Skoler,Stephanie
Publication date: 2008
Male partner involvement in the Carraguard® Phase 3 trial: Data from a qualitative study of the informed consent process (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Madiba,Sphiwe; Friedland,Barbara A.; Abbott,Sharon; Katzen,Lauren; de Kock,Alana; Cishe,Sheila
Publication date: 2008
Microbicide product development (abstract)
Maguire,Robin A.
Current Opinion in HIV and AIDS 3(5): 554-557
Publication date: 2008
Microbicides
Kaldor,John; Robbiani,Melissa
Current Opinion in HIV and AIDS 3(5)
Publication date: 2008
Microbicides: Chemistry, structure, and strategy (abstract)
Zydowsky,Thomas M.
Current Opinion in HIV and AIDS 3(5): 548-553
Publication date: 2008
No increase in cervicovaginal proinflammatory cytokines after Carraguard use in a placebo-controlledrandomized clinical trial (abstract)
Bollen,Liesbeth J.M.; Blanchard,Kelly; Kilmarx,Peter H.; Chaikummao,Supaporn; Connolly,Cathy; Wasinrapee,Punneporn; Srivirojana,Nucharee; Achalapong,Jullapong; Tappero,Jordan W.; McNicholl,Janet M.
Journal of Acquired Immune Deficiency Syndromes 47(2): 253-257
Publication date: 2008
Qualitative evaluation of the informed consent process in the Phase 3 Carraguard® efficacy trial: Study staff experiences and recommendations for future trials (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Katzen,Lauren; Friedland,Barbara A.; Abbott,Sharon; de Kock,Alana; Madiba,Sphiwe; Cishe,Sheila
Publication date: 2008
Quantification of microbicide HIV-1 anti-infective activity in vitro using an infectious virus titer reduction protocol (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Evans Strickfaden,Tammy T.; de la Torre,Nicolas; Lupo,L.Davis; Hart,Clyde E.
Publication date: 2008
Rectal microbicides (abstract)
McGowan,Ian; Anton,Peter
Current Opinion in HIV and AIDS 3(5): 593-598
Publication date: 2008
Strategies to increase male involvement and product adherence in the Phase 3 Carraguard® trial in Durban, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Makhanya,N.L.; Palanee,Thesla; Ramjee,Gita
Publication date: 2008
The contribution of behavioral research to microbicide trials: Taking stock (PDF)
plenary address at Microbicides 2008, New Delhi, India, 24-27 February
Mensch,Barbara S.
Publication date: 2008
Value of a defined HIV testing algorithm in resolution of discordant and indeterminate results in the Phase 3 Carraguard® trial, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Gehret,Marlena; Lahteenmaki,Pekka; Skoler,Stephanie; Eghan,S.; Govender,Sumentheran N.; Altini,Lydia; Ahmed,Khatija; Ramjee,Gita
Publication date: 2008
"Microbicides clinical trials in South Africa," digital media kit (HTML)
Publication date: 2007
Carrageenan/MIV-150 (PC-815), a combination microbicide (abstract)
Fernandez-Romero,Jose A.; Thorn,Mitchell; Turville,Stuart G.; Titchen,Kanani; Sudol,Kristin M.; Li,Jifan; Miller,Todd; Robbiani,Melissa; Maguire,Robin A.; Buckheit Jr.,Robert W.; Hartman,Tracy L.; Phillips,David M.
Sexually Transmitted Diseases 34(1): 9-14
Publication date: 2007
Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa (abstract) (PDF)
Ramjee,Gita; Morar,Neetha S.; Braunstein,Sarah; Friedland,Barbara A.; Jones,Heidi E.; van de Wijgert,Janneke
AIDS Research and Therapy 4(20)
Publication date: 2007
Carraguard vaginal gel safety in HIV-positive women and men in South Africa (abstract)
van de Wijgert,Janneke; Braunstein,Sarah; Morar,Neetha S.; Jones,Heidi E.; Madurai,Lorna; Evans Strickfaden,Tammy T.; Moodley,Manivasan; Aboobaker,Jamila; Ndlovu,Gugulethu; Ferguson,Taja M.; Friedland,Barbara A.; Hart,Clyde E.; Ramjee,Gita
Journal of Acquired Immune Deficiency Syndromes 46(5): 538-546
Publication date: 2007
Day of dialogue--Insights and evidence from product introduction: Lessons for microbicides (PDF)
Brady,Martha; McGrory,C.Elizabeth
Publication date: 2007
Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials (abstract)
Wallace,Andrea R.; Teitelbaum,Aaron; Wan,Livia; Mulima,Maria Gloria; Guichard,Laura; Skoler,Stephanie; Vilakazi,Hlengiwe; Mapula,Fridda S.; Rossier,Jasmine; Govender,Sumentheran N.; Lahteenmaki,Pekka; Maguire,Robin A.; Phillips,David M.
Contraception 76(1): 53-56
Publication date: 2007
Effect of a single vaginal administration of levonorgestrel in Carraguard® gel on the ovulatory process: A potential candidate for 'dual protection' emergency contraception (abstract)
Brache,Vivian; Croxatto,Horacio B.; Sitruk-Ware,Regine; Maguire,Robin A.; Montero,Juan Carlos; Kumar,Narender; Salvatierra,Ana Maria; Tejada,Ana-Sofia; Cochon,Leila; Forcelledo,Maria Luisa; Lahteenmaki,Pekka; Alvarez,Francisco; Faundes,Anibal
Contraception 76(2): 111-116
Publication date: 2007
Engaging advocates from concept to results: Summary report of the Advocates' Consultation on HIV Prevention Trials: Carraguard and VOICE Studies, Johannesburg, South Africa, 18-19 October 2007 (PDF)
meeting report
Publication date: 2007
Insights and evidence from product introduction to inform microbicides (PDF)
presentation at Population Council Microbicides Access Forum, Nairobi, 2 July
Brady,Martha
Publication date: 2007
Pharmacokinetic study to compare the absorption and tolerability of two doses of levonorgestrel following single vaginal administration of levonorgestrel in Carraguard® gel: A new formulation for 'dual protection' contraception (abstract)
Sitruk-Ware,Regine; Brache,Vivian; Maguire,Robin A.; Croxatto,Horacio B.; Kumar,Narender; Kumar,Sushma; Montero,Juan Carlos; Salvatierra,Ana Maria; Phillips,David M.; Faundes,Anibal
Contraception 75(6): 454-460
Publication date: 2007
Tests suggest new microbicide will have improved efficacy (PDF)
Population Briefs 13(2)
Publication date: 2007
Challenges in microbicide trial design and implementation (PDF)
van de Wijgert,Janneke; Jones,Heidi E.
Studies in Family Planning 37(2): 123-129
Publication date: 2006
Challenges to microbicide introduction in South Africa (abstract)
Orner,Phyllis; Harries,Jane; Cooper,Diane; Moodley,Jennifer; Hoffman,Margaret; Becker,Julie; McGrory,C.Elizabeth; Dabash,Rasha; Bracken,Hillary J.
Social Science and Medicine 63(4): 968-978
Publication date: 2006
Informed Consent in HIV Prevention Trials: Report of an International Workshop (PDF)
McGrory,C.Elizabeth; Friedland,Barbara A.; Woodsong,Cynthia; MacQueen,Kathleen M.
Publication date: 2006
Our current microbicide trials: Lessons learned and to be learned (PDF)
Skoler,Stephanie; Peterson,Leigh; Cates,Ward
The Microbicide Quarterly 4(1): 1-6
Publication date: 2006
Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women (Population Council Protocol 322): Summary (PDF)
Population Council
Publication date: 2006
Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women: Protocol synopsis (PDF)
Population Council
Publication date: 2006
Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a Phase II clinical trial (abstract)
Kilmarx,Peter H.; van de Wijgert,Janneke; Chaikummao,Supaporn; Jones,Heidi E.; Limpakarnjanarat,Kanchit; Friedland,Barbara A.; Karon,John M.; Manopaiboon,Chomnad; Srivirojana,Nucharee; Yanpaisarn,Somboonsak; Supawitkul,Somsak; Young,Nancy L.; Mock,Philip A.; Blanchard,Kelly; Mastro,Timothy D.
Journal of Acquired Immune Deficiency Syndromes 43(3): 327-334
Publication date: 2006
Safety of rectal lubricants (PDF)
presentation to the International Rectal Microbicide Working Group, Chicago, Illinois,
27 February
Phillips,David M.
Publication date: 2006
Slamming the door on unwanted guests: Why preemptive strikes at the mucosa may be the best strategy against HIV (abstract)
Trapp,Susanna; Turville,Stuart G.; Robbiani,Melissa
Journal of Leukocyte Biology 80(5): 1076-1083
Publication date: 2006
Microbicides: Developing and testing a gel to prevent HIV transmission (PDF)
Population Council Annual Report 2004
Publication date: 2005
Microbicides: Developing and testing a gel to prevent HIV transmission [Arabic] (PDF)
Population Council Annual Report 2004
Publication date: 2005
Phase III microbicide trial methodology: Opinions of experienced expanded safety trial participants in South Africa (abstract)
van de Wijgert,Janneke; Jones,Heidi E.; Pistorius,Annalie; de Kock,Alana; Sebola,Mohlatlego H.; Friedland,Barbara A.; Hoosen,Anwar; Coetzee,Nicol
Journal of Social Aspects of HIV/AIDS 2(3): 311-319
Publication date: 2005
Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing (abstract)
Braunstein,Sarah; van de Wijgert,Janneke
Journal of Women's Health 14(5): 424-433
Publication date: 2005
Assay for establishing whether microbicide applicators have been exposed to the vagina (abstract)
Wallace,Andrea R.; Thorn,Mitchell; Maguire,Robin A.; Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(8): 465-468
Publication date: 2004
Carraguard may block HIV by adhering to cells (PDF)
Population Briefs 10(1)
Publication date: 2004
Lubricants containing N-9 may enhance rectal transmission of HIV and other STIs (abstract)
Phillips,David M.; Sudol,Kristin M.; Taylor,Clark L.; Guichard,Laura; Elsen,Robert; Maguire,Robin A.
Contraception 70(2): 107-110
Publication date: 2004
Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs (abstract)
Pistorius,Annalie; van de Wijgert,Janneke; Sebola,Mohlatlego H.; Friedland,Barbara A.; Nagel,Evelyn; Bokaba,Cathleen; Hoosen,Anwar
Journal of Social Aspects of HIV/AIDS 1(2): 78-86
Publication date: 2004
Paving the Path: Preparing for Microbicide Introduction-Report of a Qualitative Study in South Africa (PDF)
Becker,Julie; Dabash,Rasha; McGrory,C.Elizabeth; Cooper,Diane; Harries,Jane; Hoffman,Margaret; Moodley,Jennifer; Orner,Phyllis; Bracken,Hillary J.
Publication date: 2004
Relative safety of sexual lubricants for rectal intercourse (abstract) (PDF)
Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(6): 346-349
Publication date: 2004
Testing Carraguard: What you need to know (PDF)
Clacherty,Glynis; Friedland,Barbara A.; de Kock,Alana; Marumo,Mabitso
Publication date: 2004
Carrageenan formulation prevents macrophage trafficking from vagina: Implications for microbicide development (abstract) (PDF)
Perotti,Maria-Elisa; Pirovano,Alessia; Phillips,David M.
Biology of Reproduction 69(3): 933-939
Publication date: 2003
Cultural norms and behavior regarding vaginal lubrication during sex: Implications for the acceptability of vaginal microbicides for the prevention of HIV/STIs (PDF)
Braunstein,Sarah; van de Wijgert,Janneke
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2003
A critical review of the toxicological effects of Carrageenan and processed eucheuma seaweed on the gastrointestinal tract (abstract)
Cohen,Samuel M.; Ito,Nobuyuki
Critical Reviews in Toxicology 32(5): 413-444
Publication date: 2002
Female condoms and microbicides
Esu-Williams,Eka; Blanchard,Kelly; Essex,Max; Mboup,Souleymane; Kanki,Phyllis J.; Marlink,Richard G.; Tlou,Sheila D.
from AIDS in Africa, pp. 506-513
Publication date: 2002
Informed consent: From good intentions to sound practices--A report of a seminar (PDF)
Wood,Susan Y.; Friedland,Barbara A.; McGrory,C.Elizabeth
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2002
Microbicides to prevent heterosexual transmission of HIV: Ten years down the road (HTML)
van de Wijgert,Janneke; Coggins,Christiana
Bulletin of Experimental Treatments for AIDS 15(2): 23-28
Publication date: 2002
Motivations for and barriers to study participation (PDF)
Population Briefs 8(1)
Publication date: 2002
Non-HIV STIs and the epidemiology of success
Blanchard,Kelly; Elias,Christopher J.
from The Science of Microbicides: Accelerating Development, report of the Science Working Group of the Microbicide Initiative, pp. 47-51
Publication date: 2002
Nonoxynol-9 rapidly exfoliates rectal epithelium (PDF)
Population Briefs, Spring 2002 (HIV/AIDS edition)
Publication date: 2002
Toward the development of a microbicide (PDF)
Population Briefs, Spring 2002 (HIV/AIDS edition)
Publication date: 2002
Acceptability and feasibility of Micralax applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides (abstract) (PDF)
Coetzee,Nicol; Blanchard,Kelly; Ellertson,Charlotte; Hoosen,Anwar; Friedland,Barbara A.
AIDS 15(14): 1837-1842
Publication date: 2001
Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? (abstract)
Elias,Christopher J.; Coggins,Christiana
Journal of Women's Health and Gender-Based Medicine 10(2): 163-173
Publication date: 2001
Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites (abstract)
van de Wijgert,Janneke; Fullem,Andrew; Kelly,Clifton; Mehendale,Sajay; Rugpao,Sungwal; Kumwenda,Newton; Chirenje,Zvavahera M.; Joshi,Mita; Taha,Taha; Padian,Nancy F.; Bollinger,Robert; Nelson,Kenrad
Journal of Acquired Immune Deficiency Syndromes 26(1): 21-27
Publication date: 2001
Recommendations for the clinical development of topical microbicides: An update (abstract) (PDF)
Mauck,Christine; Rosenberg,Zeda; Van Damme,Lut; van Dam,C.Johannes
AIDS 15(7): 857-868
Publication date: 2001
The case for microbicides: A global priority. Second edition (PDF)
Attawell,Kathy
Publication date: 2001
Women's willingness to participate in microbicide trials in northern Thailand (abstract)
Kanokwan,Tharawan; Manopaiboon,Chomnad; Ellertson,Charlotte; Limpakarnjanarat,Kanchit; Chaikummao,Supaporn; Kilmarx,Peter H.; Blanchard,Kelly; Coggins,Christiana; Mastro,Timothy D.; Elias,Christopher J.
Journal of Acquired Immune Deficiency Syndromes 28(2): 180-186
Publication date: 2001
Men's attitudes toward vaginal product use: Farmers and taxi drivers in Mexico
Coggins,Christiana; Madrigal,Mauricio Ramos; Llamas,Alicia
Publication date: 2000
Men's attitudes towards a potential vaginal microbicide in Zimbabwe, Mexico and the USA (abstract)
Coggins,Christiana; Blanchard,Kelly; Friedland,Barbara A.
Reproductive Health Matters 8(15): 132-141
Publication date: 2000
Nonoxynol-9 causes rapid exfoliation of sheets of rectal epithelium (abstract)
Phillips,David M.; Taylor,Clark L.; Zacharopoulos,Vanaja R.; Maguire,Robin A.
Contraception 62(3): 149-154
Publication date: 2000
Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide (abstract)
Coggins,Christiana; Blanchard,Kelly; Alvarez,Francisco; Brache,Vivian; Weisberg,Edith; Kilmarx,Peter H.; Lacarra,Maria; Massai,Rebeca; Mishell,Daniel R.,Jr.; Salvatierra,Ana Maria; Witwatwongwana,Paisit; Elias,Christopher J.; Ellertson,Charlotte
Sexually Transmitted Infections 76(6): 480-483
Publication date: 2000
Informing Research on HIV Prevention: A Consultation (PDF)
Fonn,Sharon; McGrory,C.Elizabeth
Publication date: 1999
Pushing the frontiers of science-the Population Council's Microbicide Basic Science Network on vaginal microbicide research (abstract)
Johansson,Elof D.B.; Maguire,Robin A.; Phillips,David M.
International Journal of Gynecology and Obstetrics 67(suppl 2): 117-124
Publication date: 1999
A study of women's preferences regarding the formulation of over-the-counter vaginal spermicides (PDF)
Coggins,Christiana; Elias,Christopher J.; Atisook,Ronachai; Bassett,Mary T.; Ettiegne-Traore,Virginie; Ghys,Peter D.; Jenkins-Woelk,Laura; Thongkrajai,Earmporn; VanDevanter,Nancy L.
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 1998
Ethical challenges in efficacy of vaginal microbicides for HIV prevention (abstract)
De Zoysa,Isabelle; Elias,Christopher J.; Bentley,Margaret E.
American Journal of Public Health 88(4): 571-575
Publication date: 1998
Practical and ethical dilemmas in the clinical testing of microbicides: A report on a symposium
Heise,Lori L.; McGrory,C.Elizabeth; Wood,Susan Y.
Publication date: 1998
Partnership for prevention: A report of a meeting between women's health advocates, program planners, and scientists (PDF)
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 1994
Towards developing a vaginal formulation which will prevent infection by human immunodeficiency virus
Phillips,David M.; Tan,Xin; Pearce-Pratt,Rachael; Zacharopoulos,Vanaja R.; Gillet,J-Y; Bongain,A.
from 2nd International Symposium on AIDS and Reproduction, pp. 229-238
Publication date: 1994
The development of microbicides: A new method of HIV prevention for women
Elias,Christopher J.; Heise,Lori L.
Programs Division Working Paper (no. 6)
Publication date: 1993
Population Council
Publication date: 2010
"The Population Council, HIV and AIDS, and microbicides," fact sheet (PDF) (HTML)
Publication date: 2009
A macaque model to study vaginal HSV-2/immunodeficiency virus co-infection and the impact of HSV-2 on microbicide efficacy (abstract) (HTML)
Crostarosa,Federica; Aravantinou,Meropi; Akpogheneta,Onome J.; Jasny,Edith; Shaw,Andrew; Kenney,Jessica; Piatak Jr.,Michael; Lifson,Jeffrey D.; Teitelbaum,Aaron; Hu,Lieyu; Chudolij,Anne; Zydowsky,Thomas M.; Blanchard,James; Gettie,Agegnehu; Robbiani,Melissa
PLoS ONE 4(11): e8060 (1)-e8060 (14)
Publication date: 2009
Acceptability of a Carrageenan-based candidate vaginal microbicide and matching placebo: Findings from a phase II safety trial among women in Chiang Rai, Thailand (abstract)
Jones,Heidi E.; Chaikummao,Supaporn; van de Wijgert,Janneke; Friedland,Barbara A.; Manopaiboon,Chomnad; Witwatwongwana,Paisit; Wankrairoj,Mayuree; Chantharojwong,Nartlada; Kilmarx,Peter H.
Journal of Women's Health 18(7): 1003-1010
Publication date: 2009
Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard® gel: A randomized, cross-over, pharmacokinetic study (abstract)
Brache,Vivian; Croxatto,Horacio B.; Kumar,Narender; Sitruk-Ware,Regine; Cochon,Leila; Schiappacasse,Veronica; Sivin,Irving; Munoz,Carla; Maguire,Robin A.; Faundes,Anibal
Contraception 79(2): 150-154
Publication date: 2009
Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews (abstract)
Turner,Abigail Norris; de Kock,Alana; Meehan-Ritter,Amy; Blanchard,Kelly; Sebola,Mohlatlego H.; Hoosen,Anwar; Coetzee,Nicol; Ellertson,Charlotte
Journal of Clinical Epidemiology 62(7): 759-765
Publication date: 2009
Trial showed anti-HIV microbicide candidate is safe, but did not prove it effective (PDF)
Population Briefs 15(1)
Publication date: 2009
Use of computer-assisted self-interview to assess product use in microbicide trials: Lessons learned in HPTN 035 (PDF)
poster presentation at the 18th International Society for Sexually Transmitted Diseases Research (ISSTDR), London, 28 June-1 July
McVarish,L.; Gorbach,P.; Mensch,Barbara S.; Coly,A.; Young,A.; Masse,Benoit R.; Makanani,B.; Chinula,L.; Nkhoma,C.; Tembo,T.; Mierzwa,Stan; Reynolds,K.; Hurst,S.; Coletti,Anne S.; Forsyth,A.
Publication date: 2009
Vaginal microbicide adherence biomarkers should be validated--Authors' reply
Skoler-Karpoff,Stephanie; Friedland,Barbara A.; Plagianos,Marlena Gehret; Maguire,Robin A.; Lahteenmaki,Pekka
Lancet 373(9665): 721-722
Publication date: 2009
Candida albicans-induced DC activation reduces HIV amplification by DCs while increasing DC-to-T-cell spread of HIV (abstract)
Vachot,Laurence; Williams,Vennansha G.; Bess Jr.,Julian W.; Lifson,Jeffrey D.; Robbiani,Melissa
Journal of Acquired Immune Deficiency Syndromes 48(4): 398-407
Publication date: 2008
A comparison between self-reported condom use and presence of spermatozoa using TV Inpouch and wet mount, among women enrolled in the Phase 3 Carraguard® clinical trial in Cape Town (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Gopolang,F.P.; Gehret,Marlena; Altini,Lydia
Publication date: 2008
A randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand (abstract)
Kilmarx,Peter H.; Blanchard,Kelly; Chaikummao,Supaporn; Friedland,Barbara A.; Srivirojana,Nucharee; Connolly,Cathy; Witwatwongwana,Paisit; Supawitkul,Somsak; Mock,Philip A.; Chaowanachan,Thanyanan; Tappero,Jordan W.
Sexually Transmitted Diseases 35(3): 226-232
Publication date: 2008
Acceptability of Carraguard® vaginal gel among HIV-infected women-Results from a randomized, controlled, crossover trial, Thailand (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Whitehead,Sara J.; McLean,C.M.; Chaikummao,Supaporn; Braunstein,Sarah; Utaivoravit,W.; van de Wijgert,Janneke; Siraprapasiri,Taweesap; Markowitz,Lauri
Publication date: 2008
Acceptability of the vaginal microbicide Carraguard® among couples in Chiang Rai, Thailand (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Martin,Sarah; Blanchard,Kelly; Manopaiboon,Chomnad; Chaikummao,Supaporn; Schaffer,Kate; Friedland,Barbara A.; Kilmarx,Peter H.
Publication date: 2008
An analysis of varying measures of adherence among women enrolled in the Carraguard® Phase 3 trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Littlefield,Sarah A.; Gehret,Marlena; Friedland,Barbara A.; Maguire,Robin A.; Govender,Sumentheran N.; Vilakazi,Hlengiwe; Carolus,N.; Rossier,Jasmine; Sibanyoni,F.; Modise,J.; Palanee,Thesla; Ramjee,Gita; de Kock,Alana; Ahmed,Khatija
Publication date: 2008
An evaluation of care and support of women who test HIV positive during the Phase 3 Carraguard® trial in South Africa (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Harries,Jane; Patel,Smruti; Cassim,Nazira; Friedland,Barbara A.; Ahmed,Khatija; Mtimkulu,Vuyelwa; Palanee,Thesla; Morar,Neetha S.; Milford,C.
Publication date: 2008
Assessing the reporting of adherence and sexual activity in a simulated microbicide trial: Preliminary results from an interview mode experiment in the Phase 3 Carraguard® sites, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Mensch,Barbara S.; Hewett,Paul C.; Rankin,Johanna; Littlefield,Sarah A.; Abbott,Sharon; Ahmed,Khatija; Cassim,Nazira; Patel,Smruti; Mehlomakulu,Vuyelwa; Ramjee,Gita; Palanee,Thesla; Skoler,Stephanie; Gehret,Marlena; Govender,Sumentheran N.
Publication date: 2008
Challenges and results of including 16-17-year-old women in the Carraguard® Phase 3 efficacy trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Skoler,Stephanie; Friedland,Barbara A.; Gehret,Marlena; Ngcozela,N.; Mthembu,P.N.; Palanee,Thesla; de Kock,Alana; Ahmed,Khatija; Malebo Ratlhagana,Mary-Jane
Publication date: 2008
Community misunderstandings arising from premature closure of cellulose sulfate trial and scheduled completion of Carraguard trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Mthembu,P.N.; Palanee,Thesla; Ramjee,Gita
Publication date: 2008
Consentement éclairé dans les essais de prévention du VIH: Points saillants d'un atelier international [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Consentimento informado nos ensaios de prevenção do HIV: Pontos altos dum workshop internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Consentimiento informado en ensayos de prevención del VIH: Aspectos destacados de un taller internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Decision making and the influences of others in the informed consent process: A qualitative investigation in the Phase 3 study of Carraguard® (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Abbott,Sharon; Friedland,Barbara A.; Katzen,Lauren; de Kock,Alana; Madiba,Sphiwe; Cishe,Sheila
Publication date: 2008
Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials (abstract)
van de Wijgert,Janneke; Kilmarx,Peter H.; Jones,Heidi E.; Karon,John M.; Chaikummao,Supaporn
Contraception 77(2): 122-129
Publication date: 2008
Efficacy of Carraguard for prevention of HIV infection in women in South Africa: A randomised, double-blind, placebo-controlled trial (abstract)
Skoler-Karpoff,Stephanie; Ramjee,Gita; Ahmed,Khatija; Altini,Lydia; Gehret,Marlena; Friedland,Barbara A.; Govender,Sumentheran N.; de Kock,Alana; Cassim,Nazira; Palanee,Thesla; Dozier,Gregory; Maguire,Robin A.; Lahteenmaki,Pekka
Lancet 372(9654): 1977-1987
Publication date: 2008
Efficacy of Carraguard-based microbicides in vivo despite variable in vitro activity (abstract) (PDF)
Turville,Stuart G.; Aravantinou,Meropi; Miller,Todd; Kenney,Jessica; Teitelbaum,Aaron; Hu,Lieyu; Chudolij,Anne; Zydowsky,Thomas M.; Piatak Jr.,Michael; Bess Jr.,Julian W.; Lifson,Jeffrey D.; Blanchard,James; Gettie,Agegnehu; Robbiani,Melissa
PLoS ONE 3(9): e3162-
Publication date: 2008
Ensuring care through adequate referrals and community partnerships for women participating in HIV prevention trials: Experience from the Phase 3 Carraguard® trial in Isipingo, KwaZulu Natal, Durban, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Ramjee,Gita
Publication date: 2008
Establishing the standard of care in HIV prevention trials: Experience of Setshaba Research Centre (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Ahmed,Khatija
Publication date: 2008
Evaluation of a video to enhance the informed consent process in the Phase 3 Carraguard® trial (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Friedland,Barbara A.; Skoler,Stephanie; de Kock,Alana; Katzen,Lauren; Apicella,Louis; Williams,Manuela M.; Mehlomakulu,Vuyelwa; Mtimkulu,Vuyelwa
Publication date: 2008
Idhini fahamishi katika majaribio ya kikliniki ya ukingaji wa virusi vya ukimwi [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Impact of acceptability on adherence in the Carraguard® Phase 3 trial (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Friedland,Barbara A.; Littlefield,Sarah A.; Skoler,Stephanie; de Kock,Alana; Palanee,Thesla; Gehret,Marlena; Katzen,Lauren; Morar,Neetha S.; Mehlomakulu,Vuyelwa; Williams,Manuela M.
Publication date: 2008
Impact of provision of hormonal contraception on pregnancy incidence in women enrolled in the Phase 3 Carraguard® clinical trial at three sites in South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Cele,N.; Palanee,Thesla; Myeni,N.; Mnyandu,N.; Langa,Z.; Shange,E.; Gehret,Marlena; Lahteenmaki,Pekka; Skoler,Stephanie; Altini,Lydia; Patel,Smruti; Ahmed,Khatija; Cassim,Nazira; Ramjee,Gita
Publication date: 2008
Imvume unolwazi ocwaningweni lokuvimbela igciwane lesandulela ngculaza [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Incidence and point prevalence of sexually transmitted and reproductive tract infections among women enrolled in the Phase 3 Carraguard® trial in South Africa (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Gehret,Marlena; Skoler,Stephanie; Lahteenmaki,Pekka; Friedland,Barbara A.; Patel,Smruti; Ahmed,Khatija; Cassim,Nazira; Altini,Lydia; Morar,Neetha S.; Govender,Sumentheran N.; Zhou,Lifen; Ramjee,Gita
Publication date: 2008
Informed consent in HIV prevention trials: Highlights from an international workshop (PDF)
Publication date: 2008
Male partner circumcision and HIV seroconversion among participants in the Phase 3 Carraguard® microbicide trial (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Gehret,Marlena; Palanee,Thesla; Skhosana,Joseph; Friedland,Barbara A.; Littlefield,Sarah A.; de Kock,Alana; Williams,Nela; Skoler,Stephanie
Publication date: 2008
Male partner involvement in the Carraguard® Phase 3 trial: Data from a qualitative study of the informed consent process (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Madiba,Sphiwe; Friedland,Barbara A.; Abbott,Sharon; Katzen,Lauren; de Kock,Alana; Cishe,Sheila
Publication date: 2008
Microbicide product development (abstract)
Maguire,Robin A.
Current Opinion in HIV and AIDS 3(5): 554-557
Publication date: 2008
Microbicides
Kaldor,John; Robbiani,Melissa
Current Opinion in HIV and AIDS 3(5)
Publication date: 2008
Microbicides: Chemistry, structure, and strategy (abstract)
Zydowsky,Thomas M.
Current Opinion in HIV and AIDS 3(5): 548-553
Publication date: 2008
No increase in cervicovaginal proinflammatory cytokines after Carraguard use in a placebo-controlledrandomized clinical trial (abstract)
Bollen,Liesbeth J.M.; Blanchard,Kelly; Kilmarx,Peter H.; Chaikummao,Supaporn; Connolly,Cathy; Wasinrapee,Punneporn; Srivirojana,Nucharee; Achalapong,Jullapong; Tappero,Jordan W.; McNicholl,Janet M.
Journal of Acquired Immune Deficiency Syndromes 47(2): 253-257
Publication date: 2008
Qualitative evaluation of the informed consent process in the Phase 3 Carraguard® efficacy trial: Study staff experiences and recommendations for future trials (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Katzen,Lauren; Friedland,Barbara A.; Abbott,Sharon; de Kock,Alana; Madiba,Sphiwe; Cishe,Sheila
Publication date: 2008
Quantification of microbicide HIV-1 anti-infective activity in vitro using an infectious virus titer reduction protocol (PDF)
presentation at Microbicides 2008, New Delhi, India, 24-27 February
Evans Strickfaden,Tammy T.; de la Torre,Nicolas; Lupo,L.Davis; Hart,Clyde E.
Publication date: 2008
Rectal microbicides (abstract)
McGowan,Ian; Anton,Peter
Current Opinion in HIV and AIDS 3(5): 593-598
Publication date: 2008
Strategies to increase male involvement and product adherence in the Phase 3 Carraguard® trial in Durban, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Makhanya,N.L.; Palanee,Thesla; Ramjee,Gita
Publication date: 2008
The contribution of behavioral research to microbicide trials: Taking stock (PDF)
plenary address at Microbicides 2008, New Delhi, India, 24-27 February
Mensch,Barbara S.
Publication date: 2008
Value of a defined HIV testing algorithm in resolution of discordant and indeterminate results in the Phase 3 Carraguard® trial, South Africa (PDF)
poster presented at Microbicides 2008, New Delhi, India, 24-27 February
Palanee,Thesla; Gehret,Marlena; Lahteenmaki,Pekka; Skoler,Stephanie; Eghan,S.; Govender,Sumentheran N.; Altini,Lydia; Ahmed,Khatija; Ramjee,Gita
Publication date: 2008
"Microbicides clinical trials in South Africa," digital media kit (HTML)
Publication date: 2007
Carrageenan/MIV-150 (PC-815), a combination microbicide (abstract)
Fernandez-Romero,Jose A.; Thorn,Mitchell; Turville,Stuart G.; Titchen,Kanani; Sudol,Kristin M.; Li,Jifan; Miller,Todd; Robbiani,Melissa; Maguire,Robin A.; Buckheit Jr.,Robert W.; Hartman,Tracy L.; Phillips,David M.
Sexually Transmitted Diseases 34(1): 9-14
Publication date: 2007
Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa (abstract) (PDF)
Ramjee,Gita; Morar,Neetha S.; Braunstein,Sarah; Friedland,Barbara A.; Jones,Heidi E.; van de Wijgert,Janneke
AIDS Research and Therapy 4(20)
Publication date: 2007
Carraguard vaginal gel safety in HIV-positive women and men in South Africa (abstract)
van de Wijgert,Janneke; Braunstein,Sarah; Morar,Neetha S.; Jones,Heidi E.; Madurai,Lorna; Evans Strickfaden,Tammy T.; Moodley,Manivasan; Aboobaker,Jamila; Ndlovu,Gugulethu; Ferguson,Taja M.; Friedland,Barbara A.; Hart,Clyde E.; Ramjee,Gita
Journal of Acquired Immune Deficiency Syndromes 46(5): 538-546
Publication date: 2007
Day of dialogue--Insights and evidence from product introduction: Lessons for microbicides (PDF)
Brady,Martha; McGrory,C.Elizabeth
Publication date: 2007
Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials (abstract)
Wallace,Andrea R.; Teitelbaum,Aaron; Wan,Livia; Mulima,Maria Gloria; Guichard,Laura; Skoler,Stephanie; Vilakazi,Hlengiwe; Mapula,Fridda S.; Rossier,Jasmine; Govender,Sumentheran N.; Lahteenmaki,Pekka; Maguire,Robin A.; Phillips,David M.
Contraception 76(1): 53-56
Publication date: 2007
Effect of a single vaginal administration of levonorgestrel in Carraguard® gel on the ovulatory process: A potential candidate for 'dual protection' emergency contraception (abstract)
Brache,Vivian; Croxatto,Horacio B.; Sitruk-Ware,Regine; Maguire,Robin A.; Montero,Juan Carlos; Kumar,Narender; Salvatierra,Ana Maria; Tejada,Ana-Sofia; Cochon,Leila; Forcelledo,Maria Luisa; Lahteenmaki,Pekka; Alvarez,Francisco; Faundes,Anibal
Contraception 76(2): 111-116
Publication date: 2007
Engaging advocates from concept to results: Summary report of the Advocates' Consultation on HIV Prevention Trials: Carraguard and VOICE Studies, Johannesburg, South Africa, 18-19 October 2007 (PDF)
meeting report
Publication date: 2007
Insights and evidence from product introduction to inform microbicides (PDF)
presentation at Population Council Microbicides Access Forum, Nairobi, 2 July
Brady,Martha
Publication date: 2007
Pharmacokinetic study to compare the absorption and tolerability of two doses of levonorgestrel following single vaginal administration of levonorgestrel in Carraguard® gel: A new formulation for 'dual protection' contraception (abstract)
Sitruk-Ware,Regine; Brache,Vivian; Maguire,Robin A.; Croxatto,Horacio B.; Kumar,Narender; Kumar,Sushma; Montero,Juan Carlos; Salvatierra,Ana Maria; Phillips,David M.; Faundes,Anibal
Contraception 75(6): 454-460
Publication date: 2007
Tests suggest new microbicide will have improved efficacy (PDF)
Population Briefs 13(2)
Publication date: 2007
Challenges in microbicide trial design and implementation (PDF)
van de Wijgert,Janneke; Jones,Heidi E.
Studies in Family Planning 37(2): 123-129
Publication date: 2006
Challenges to microbicide introduction in South Africa (abstract)
Orner,Phyllis; Harries,Jane; Cooper,Diane; Moodley,Jennifer; Hoffman,Margaret; Becker,Julie; McGrory,C.Elizabeth; Dabash,Rasha; Bracken,Hillary J.
Social Science and Medicine 63(4): 968-978
Publication date: 2006
Informed Consent in HIV Prevention Trials: Report of an International Workshop (PDF)
McGrory,C.Elizabeth; Friedland,Barbara A.; Woodsong,Cynthia; MacQueen,Kathleen M.
Publication date: 2006
Our current microbicide trials: Lessons learned and to be learned (PDF)
Skoler,Stephanie; Peterson,Leigh; Cates,Ward
The Microbicide Quarterly 4(1): 1-6
Publication date: 2006
Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women (Population Council Protocol 322): Summary (PDF)
Population Council
Publication date: 2006
Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women: Protocol synopsis (PDF)
Population Council
Publication date: 2006
Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a Phase II clinical trial (abstract)
Kilmarx,Peter H.; van de Wijgert,Janneke; Chaikummao,Supaporn; Jones,Heidi E.; Limpakarnjanarat,Kanchit; Friedland,Barbara A.; Karon,John M.; Manopaiboon,Chomnad; Srivirojana,Nucharee; Yanpaisarn,Somboonsak; Supawitkul,Somsak; Young,Nancy L.; Mock,Philip A.; Blanchard,Kelly; Mastro,Timothy D.
Journal of Acquired Immune Deficiency Syndromes 43(3): 327-334
Publication date: 2006
Safety of rectal lubricants (PDF)
presentation to the International Rectal Microbicide Working Group, Chicago, Illinois,
27 February
Phillips,David M.
Publication date: 2006
Slamming the door on unwanted guests: Why preemptive strikes at the mucosa may be the best strategy against HIV (abstract)
Trapp,Susanna; Turville,Stuart G.; Robbiani,Melissa
Journal of Leukocyte Biology 80(5): 1076-1083
Publication date: 2006
Microbicides: Developing and testing a gel to prevent HIV transmission (PDF)
Population Council Annual Report 2004
Publication date: 2005
Microbicides: Developing and testing a gel to prevent HIV transmission [Arabic] (PDF)
Population Council Annual Report 2004
Publication date: 2005
Phase III microbicide trial methodology: Opinions of experienced expanded safety trial participants in South Africa (abstract)
van de Wijgert,Janneke; Jones,Heidi E.; Pistorius,Annalie; de Kock,Alana; Sebola,Mohlatlego H.; Friedland,Barbara A.; Hoosen,Anwar; Coetzee,Nicol
Journal of Social Aspects of HIV/AIDS 2(3): 311-319
Publication date: 2005
Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing (abstract)
Braunstein,Sarah; van de Wijgert,Janneke
Journal of Women's Health 14(5): 424-433
Publication date: 2005
Assay for establishing whether microbicide applicators have been exposed to the vagina (abstract)
Wallace,Andrea R.; Thorn,Mitchell; Maguire,Robin A.; Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(8): 465-468
Publication date: 2004
Carraguard may block HIV by adhering to cells (PDF)
Population Briefs 10(1)
Publication date: 2004
Lubricants containing N-9 may enhance rectal transmission of HIV and other STIs (abstract)
Phillips,David M.; Sudol,Kristin M.; Taylor,Clark L.; Guichard,Laura; Elsen,Robert; Maguire,Robin A.
Contraception 70(2): 107-110
Publication date: 2004
Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs (abstract)
Pistorius,Annalie; van de Wijgert,Janneke; Sebola,Mohlatlego H.; Friedland,Barbara A.; Nagel,Evelyn; Bokaba,Cathleen; Hoosen,Anwar
Journal of Social Aspects of HIV/AIDS 1(2): 78-86
Publication date: 2004
Paving the Path: Preparing for Microbicide Introduction-Report of a Qualitative Study in South Africa (PDF)
Becker,Julie; Dabash,Rasha; McGrory,C.Elizabeth; Cooper,Diane; Harries,Jane; Hoffman,Margaret; Moodley,Jennifer; Orner,Phyllis; Bracken,Hillary J.
Publication date: 2004
Relative safety of sexual lubricants for rectal intercourse (abstract) (PDF)
Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(6): 346-349
Publication date: 2004
Testing Carraguard: What you need to know (PDF)
Clacherty,Glynis; Friedland,Barbara A.; de Kock,Alana; Marumo,Mabitso
Publication date: 2004
Carrageenan formulation prevents macrophage trafficking from vagina: Implications for microbicide development (abstract) (PDF)
Perotti,Maria-Elisa; Pirovano,Alessia; Phillips,David M.
Biology of Reproduction 69(3): 933-939
Publication date: 2003
Cultural norms and behavior regarding vaginal lubrication during sex: Implications for the acceptability of vaginal microbicides for the prevention of HIV/STIs (PDF)
Braunstein,Sarah; van de Wijgert,Janneke
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2003
A critical review of the toxicological effects of Carrageenan and processed eucheuma seaweed on the gastrointestinal tract (abstract)
Cohen,Samuel M.; Ito,Nobuyuki
Critical Reviews in Toxicology 32(5): 413-444
Publication date: 2002
Female condoms and microbicides
Esu-Williams,Eka; Blanchard,Kelly; Essex,Max; Mboup,Souleymane; Kanki,Phyllis J.; Marlink,Richard G.; Tlou,Sheila D.
from AIDS in Africa, pp. 506-513
Publication date: 2002
Informed consent: From good intentions to sound practices--A report of a seminar (PDF)
Wood,Susan Y.; Friedland,Barbara A.; McGrory,C.Elizabeth
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2002
Microbicides to prevent heterosexual transmission of HIV: Ten years down the road (HTML)
van de Wijgert,Janneke; Coggins,Christiana
Bulletin of Experimental Treatments for AIDS 15(2): 23-28
Publication date: 2002
Motivations for and barriers to study participation (PDF)
Population Briefs 8(1)
Publication date: 2002
Non-HIV STIs and the epidemiology of success
Blanchard,Kelly; Elias,Christopher J.
from The Science of Microbicides: Accelerating Development, report of the Science Working Group of the Microbicide Initiative, pp. 47-51
Publication date: 2002
Nonoxynol-9 rapidly exfoliates rectal epithelium (PDF)
Population Briefs, Spring 2002 (HIV/AIDS edition)
Publication date: 2002
Toward the development of a microbicide (PDF)
Population Briefs, Spring 2002 (HIV/AIDS edition)
Publication date: 2002
Acceptability and feasibility of Micralax applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides (abstract) (PDF)
Coetzee,Nicol; Blanchard,Kelly; Ellertson,Charlotte; Hoosen,Anwar; Friedland,Barbara A.
AIDS 15(14): 1837-1842
Publication date: 2001
Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? (abstract)
Elias,Christopher J.; Coggins,Christiana
Journal of Women's Health and Gender-Based Medicine 10(2): 163-173
Publication date: 2001
Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites (abstract)
van de Wijgert,Janneke; Fullem,Andrew; Kelly,Clifton; Mehendale,Sajay; Rugpao,Sungwal; Kumwenda,Newton; Chirenje,Zvavahera M.; Joshi,Mita; Taha,Taha; Padian,Nancy F.; Bollinger,Robert; Nelson,Kenrad
Journal of Acquired Immune Deficiency Syndromes 26(1): 21-27
Publication date: 2001
Recommendations for the clinical development of topical microbicides: An update (abstract) (PDF)
Mauck,Christine; Rosenberg,Zeda; Van Damme,Lut; van Dam,C.Johannes
AIDS 15(7): 857-868
Publication date: 2001
The case for microbicides: A global priority. Second edition (PDF)
Attawell,Kathy
Publication date: 2001
Women's willingness to participate in microbicide trials in northern Thailand (abstract)
Kanokwan,Tharawan; Manopaiboon,Chomnad; Ellertson,Charlotte; Limpakarnjanarat,Kanchit; Chaikummao,Supaporn; Kilmarx,Peter H.; Blanchard,Kelly; Coggins,Christiana; Mastro,Timothy D.; Elias,Christopher J.
Journal of Acquired Immune Deficiency Syndromes 28(2): 180-186
Publication date: 2001
Men's attitudes toward vaginal product use: Farmers and taxi drivers in Mexico
Coggins,Christiana; Madrigal,Mauricio Ramos; Llamas,Alicia
Publication date: 2000
Men's attitudes towards a potential vaginal microbicide in Zimbabwe, Mexico and the USA (abstract)
Coggins,Christiana; Blanchard,Kelly; Friedland,Barbara A.
Reproductive Health Matters 8(15): 132-141
Publication date: 2000
Nonoxynol-9 causes rapid exfoliation of sheets of rectal epithelium (abstract)
Phillips,David M.; Taylor,Clark L.; Zacharopoulos,Vanaja R.; Maguire,Robin A.
Contraception 62(3): 149-154
Publication date: 2000
Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide (abstract)
Coggins,Christiana; Blanchard,Kelly; Alvarez,Francisco; Brache,Vivian; Weisberg,Edith; Kilmarx,Peter H.; Lacarra,Maria; Massai,Rebeca; Mishell,Daniel R.,Jr.; Salvatierra,Ana Maria; Witwatwongwana,Paisit; Elias,Christopher J.; Ellertson,Charlotte
Sexually Transmitted Infections 76(6): 480-483
Publication date: 2000
Informing Research on HIV Prevention: A Consultation (PDF)
Fonn,Sharon; McGrory,C.Elizabeth
Publication date: 1999
Pushing the frontiers of science-the Population Council's Microbicide Basic Science Network on vaginal microbicide research (abstract)
Johansson,Elof D.B.; Maguire,Robin A.; Phillips,David M.
International Journal of Gynecology and Obstetrics 67(suppl 2): 117-124
Publication date: 1999
A study of women's preferences regarding the formulation of over-the-counter vaginal spermicides (PDF)
Coggins,Christiana; Elias,Christopher J.; Atisook,Ronachai; Bassett,Mary T.; Ettiegne-Traore,Virginie; Ghys,Peter D.; Jenkins-Woelk,Laura; Thongkrajai,Earmporn; VanDevanter,Nancy L.
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 1998
Ethical challenges in efficacy of vaginal microbicides for HIV prevention (abstract)
De Zoysa,Isabelle; Elias,Christopher J.; Bentley,Margaret E.
American Journal of Public Health 88(4): 571-575
Publication date: 1998
Practical and ethical dilemmas in the clinical testing of microbicides: A report on a symposium
Heise,Lori L.; McGrory,C.Elizabeth; Wood,Susan Y.
Publication date: 1998
Partnership for prevention: A report of a meeting between women's health advocates, program planners, and scientists (PDF)
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 1994
Towards developing a vaginal formulation which will prevent infection by human immunodeficiency virus
Phillips,David M.; Tan,Xin; Pearce-Pratt,Rachael; Zacharopoulos,Vanaja R.; Gillet,J-Y; Bongain,A.
from 2nd International Symposium on AIDS and Reproduction, pp. 229-238
Publication date: 1994
The development of microbicides: A new method of HIV prevention for women
Elias,Christopher J.; Heise,Lori L.
Programs Division Working Paper (no. 6)
Publication date: 1993
What's New
- Naomi Rutenberg, Population Council vice president and director of the HIV and AIDS program, discussed the results of the CAPRISA study on PRI's "The Takeaway." (offsite link)
- Breakthrough in microbicide research: A gel tested by CAPRISA in South Africa indicates that it is safe and effective in reducing the risk of HIV and herpes infections among women participants; confirmatory research is needed. (more)
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