New HIV prevention methods are urgently needed; worldwide, 2.7 million individuals are infected each year. User-controlled prevention methods called microbicides will allow women and men to protect themselves from HIV as well as other sexually transmitted infections.
Today, Council researchers are developing vaginal and rectal microbicides that will allow heterosexual couples and men who have sex with men to prevent HIV and other sexually transmitted infections. In addition, the Council is developing combined microbicide/contraceptive products, which also provide protection against unintended pregnancy.
Developing solutions
The Council's comprehensive approach to microbicides development comprises all aspects of research, from the laboratory to the field, product introduction, and public education.
In the lab, the current product pipeline includes next-generation gels formulated in carrageenan (CG; a natural polymer obtained from seaweed) as well as other natural and man-made polymers that contain one or more active pharmaceutical ingredients and can be used independently of coitus. Researchers are also developing vaginal rings that remain in place for 1–3 months for long-acting delivery of anti-HIV and herpes simplex virus type 2 (HSV-2) compounds.
Complementary social science and behavioral 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 Population Council work includes:
- Basic science research (since 1989) on the sexual transmission of HIV and screening compounds for potential microbicidal activity. The dendritic cell, a type of white blood cell, plays a critical role in driving HIV infection in T cells. Novel strategies are being tested in vitro and in vivo for their ability to suppress dendritic cell-driven virus growth.
- Collaborating with other groups to develop and test innovative ways to objectively validate reporting of adherence to study products (e.g., rapid stain identification of human semen, dye stain assays, and Wisebag™) and to improve reporting (e.g., using audio computer-assisted self-interviewing [ACASI)] and interactive voice response surveys).
- Examining the use of alternative recruitment strategies for enrolling clinical trial participants who are highly motivated to follow the protocol and who are representative of the women who might eventually use the product.
- Partnering with organizations to develop an educational video to inform communities, potential participants, advocates, and clinical trial staff about rectal microbicide clinical trials.
- Creating a database of field-tested translations of terms used in clinical trials to ensure consistency among trials.
Making an impact
Council research has contributed to advances in the laboratory and the field:
- The Council conceived, developed, and tested Carraguard®, an aqueous gel containing CG. 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.
- Preclinical research by the Council determined that MIV-150 (an enzyme inhibitor developed by Medivir that prevents HIV-infected cells from producing new virus) combined with zinc acetate (ZA, an antiviral agent with activity against HIV and HSV) in a CG gel significantly reduces vaginal infection of macaques for up to 24 hours after gel application. The gel is advancing into clinical testing. Zinc-containing gels have also been shown to be highly effective at preventing vaginal and rectal infection of mice with HSV-2.
- The Council also provided the first proof-of-concept data that MIV-150 delivered in a vaginal ring can prevent immunodeficiency virus infection of macaques, setting the stage to further develop a MIV-150/ZA ring.
- The Council developed and validated a dye stain assay using biomarkers to confirm whether a microbicide applicator has been used by study participants—providing an objective measure of adherence in addition to self-reports.
- The Council recently completed a placebo microbicide trial, which provided important information on how to effectively recruit trial participants that will be used in future clinical trials.
Future directions
Council staff will continue to conduct basic research in immunology and make efforts to develop and introduce a safe and effective microbicide. Researchers will advance lead microbicide formulations, MIV-150/ZA/CG (gel), ZA/CG (gel), and MIV-150/ZA (ring) through final preclinical testing into clinical testing and continue to investigate novel ways to deliver MIV-150, zinc, and other agents. The Council has initiated research on combined microbicide/contraceptive gels and rings capitalizing on the Council's progress with contraceptive design and introduction. Council staff are also conducting additional studies aimed at improving methodology for future clinical trials.
Projects
Audio Computer-assisted Self-interviewing (ACASI) (more)
Population Council researchers and information technology specialists have developed software for interviewees responding to sensitive questions.
(1/1999 - ongoing)
Global
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
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 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
Facilitating Regulatory Approval of Multipurpose Prevention Technologies for Reproductive Health (more)
The Population Council is playing a central role in the US Agency for International Development’s effort to clarify and inform regulatory pathways for multipurpose prevention technologies.
(10/2010 - 9/2013)
United States
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 - 1/2012)
India
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
Resources
An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India (abstract) (HTML)
Abbott,Sharon; Friedland,Barbara A.; Sarna,Avina; Katzen,Lauren L.; Rawiel,Ulrike; Srikrishnan,Aylur K.; Shalini,C.S.; Tun,Waimar; Kelly,Christine A.; Solomon,Suniti; Mensch,Barbara S.
AIDS and Behavior 17(6): 2222-2236
Publication date: 2013
Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial (abstract) (HTML)
Mensch,Barbara S.; Friedland,Barbara A.; Abbott,Sharon; Katzen,Lauren L.; Tun,Waimar; Kelly,Clifton A.; Sarna,Avina; Srikrishnan,Aylur K.; Solomon,Suniti
AIDS and Behavior 17(2): 585-597
Publication date: 2013
Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial (abstract) (PDF)
Gorbach,Pamina M.; Mensch,Barbara S.; Husnik,Marla; Coly,Astou; Masse,Benoit R.; Makanani,Bonus; Nkhoma,Chiwawa; Chinula,Lameck; Tembo,Tchangani; Mierzwa,Stan; Reynolds,Kimberly; Hurst,Stacey; Coletti,Anne S.; Forsyth,Andrew
AIDS and Behavior 17(2): 790-800
Publication date: 2013
In search of the optimal delivery method for anti-HIV microbicides: Are intravaginal rings the way forward? (abstract) (HTML)
Derby,Nina R.; Zydowsky,Thomas M.; Robbiani,Melissa
Expert Review of Anti-infective Therapy 11(1): 5-8
Publication date: 2013
Microbicide clinical trial adherence: Insights for introduction (abstract) (PDF)
Woodsong,Cynthia; MacQueen,Kathleen M.; Amico,K.Rivet; Friedland,Barbara A.; Gafos,Mitzy; Mansoor,Leila; Tolley,Elizabeth E.; McCormack,Sheena
Journal of the International AIDS Society 16: 18505-
Publication date: 2013
Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009) (abstract) (HTML)
Parikh,Urvi M.; Kiepiela,Photini; Ganesh,Shayhana; Gomez,Kailazarid; Horn,Stephanie; Eskay,Krista; Kelly,Cliff; Mensch,Barbara S.; Gorbach,Pamina M.; Soto-Torres,Lydia; Ramjee,Gita; Mellors,John W.; on behalf of IPTc Taskforce
PLoS ONE 8(4): e59787-
Publication date: 2013
Sexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, India (abstract) (HTML)
Sarna,Avina; Friedland,Barbara A.; Srikrishnan,Aylur K.; Katzen,Lauren L.; Tun,Waimar; Abbott,Sharon; Rawiel,Ulrike; Kelly,Christine A.; Shalini,C.S.; Solomon,Suniti; Mensch,Barbara S.
Global Journal of Health Science 5(3): 139-149
Publication date: 2013
"Microbicide research and development," fact sheet (PDF)
Population Council
Publication date: 2012
"The Population Council's HIV and AIDS program," fact sheet (PDF)
Population Council
Publication date: 2012
A single dose of a MIV-150/zinc acetate gel provides 24 h of protection against vaginal simian human immunodeficiency virus reverse transcriptase infection, with more limited protection rectally 8-24 h after gel use (abstract) (HTML)
Kenney,Jessica; Singer,Rachel; Derby,Nina R.; Aravantinou,Meropi; Abraham,Ciby J.; Menon,Radhika; Seidor,Samantha; Zhang,Shimin; Gettie,Agegnehu; Blanchard,James; Piatak Jr.,Michael; Lifson,Jeffrey D.; Fernandez-Romero,Jose A.; Zydowsky,Thomas M.; Robbiani,Melissa
AIDS Research and Human Retroviruses 28(11): 1476-1484
Publication date: 2012
Acceptability in microbicide and PrEP trials: Current status and a reconceptualization (abstract) (HTML)
Mensch,Barbara S.; van der Straten,Ariane; Katzen,Lauren L.
Current Opinion in HIV and AIDS 7(6): 534-541
Publication date: 2012
An intravaginal ring that releases the NNRTI MIV-150 reduces SHIV transmission in macaques (abstract) (HTML)
Singer,Rachel; Mawson,Paul; Derby,Nina R.; Rodriguez,Aixa; Kizima,Larisa; Menon,Radhika; Goldman,Daniel; Kenney,Jessica; Aravantinou,Meropi; Seidor,Samantha; Gettie,Agegnehu; Blanchard,James; Piatak Jr.,Michael; Lifson,Jeffrey D.; Fernandez-Romero,Jose A.; Robbiani,Melissa; Zydowsky,Thomas M.
Science Translational Medicine 4(150)
Publication date: 2012
Hormonal contraception and the risk of HIV acquisition among women in South Africa (abstract) (HTML)
Morrison,Charles S.; Skoler-Karpoff,Stephanie; Kwok,Cynthia; Chen,Pai-lien; van de Wijgert,Janneke; Gehret-Plagianos,Marlena; Patel,Smruti; Ahmed,Khatija; Ramjee,Gita; Friedland,Barbara A.; Lahteenmaki,Pekka
AIDS 26(4): 497-504
Publication date: 2012
Nonclinical development needs and regulatory requirements for multipurpose prevention technologies: A primer (PDF)
Romano,Joseph W.; Brady,Martha; Manning,Judy
Publication date: 2012
Non-specific microbicide development: Then and now (abstract) (HTML)
Romano,Joseph W.; Robbiani,Melissa; Doncel,Gustavo F.; Moench,Thomas
Current HIV Research 10(1): 9-18
Publication date: 2012
Shaping the operations research agenda for antiretroviral-based prevention products for women: Gels and rings (PDF)
Brady,Martha; McGrory,C.Elizabeth
Consultation Report
Publication date: 2012
The nonnucleoside reverse transcription inhibitor MIV-160 delivered from an intravaginal ring, but not from a carrageenan gel, protects against simian/human immunodeficiency virus-RT infection (abstract) (PDF)
Aravantinou,Meropi; Singer,Rachel; Derby,Nina R.; Calenda,Giulia; Mawson,Paul; Abraham,Ciby J.; Menon,Radhika; Seidor,Samantha; Goldman,Daniel; Kenney,Jessica; Villegas,Guillermo; Gettie,Agegnehu; Blanchard,James; Lifson,Jeffrey D.; Piatak Jr.,Michael; Fernandez-Romero,Jose A.; Zydowsky,Thomas M.; Teleshova,Natalia; Robbiani,Melissa
AIDS Research and Human Retroviruses 28(11): 1467-1475
Publication date: 2012
Users' and providers' perspectives on MPTs: What do we know, and what do we need to know? (PDF)
Presentation at Multipurpose Prevention Technologies for Reproductive Health, New Delhi, India, 11-12 December
Brady,Martha
Publication date: 2012
What have we learned from other reproductive health technologies? (PDF)
Presentation at Multipurpose Prevention Technologies for Reproductive Health, New Delhi, India, 11-12 December
Brady,Martha
Publication date: 2012
Zinc acetate/carrageenan gels exhibit potent activity in vivo against high dose HSV-2 vaginal and rectal challenge (abstract) (PDF)
Fernandez-Romero,Jose A.; Abraham,Ciby J.; Rodriguez,Aixa; Kizima,Larisa; Jean-Pierre,Ninochka; Menon,Radhika; Begay,Othell; Seidor,Samantha; Ford,Brian E.; Gil,Pedro I.; Peters,Jennifer; Katz,David; Robbiani,Melissa; Zydowsky,Thomas M.
Antimicrobial Agents and Chemotherapy 56(1): 358-368
Publication date: 2012
Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang Rai, Thailand (abstract) (HTML)
Whitehead,Sara J.; McLean,Catherine A.; Chaikummao,Supaporn; Braunstein,Sarah; Utaivoravit,Wat; van de Wijgert,Janneke; Mock,Philip A.; Siraprapasiri,Taweesap; Friedland,Barbara A.; Kilmarx,Peter H.; Markowitz,Lauri
PLoS ONE 6(9): e14831-
Publication date: 2011
An antiretroviral/zinc combination gel provides 24 hours of complete protection against vaginal SHIV infection in macaques (abstract) (PDF)
Kenney,Jessica; Aravantinou,Meropi; Singer,Rachel; Hsu,Mayla; Rodriguez,Aixa; Kizima,Larisa; Abraham,Ciby J.; Menon,Radhika; Seidor,Samantha; Chudolij,Anne; Gettie,Agegnehu; Blanchard,James; Lifson,Jeffrey D.; Piatak Jr.,Michael; Fernandez-Romero,Jose A.; Zydowsky,Thomas M.; Robbiani,Melissa
PLoS ONE 6(1): E15835-
Publication date: 2011
Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: An interview mode experiment using a placebo gel (abstract) (HTML)
Mensch,Barbara S.; Hewett,Paul C.; Abbott,Sharon; Rankin,Johanna; Littlefield,Sarah A.; Ahmed,Khatija; Cassim,Nazira; Patel,Smruti; Ramjee,Gita; Palanee,Thesla; Mierzwa,Stan; Skoler-Karpoff,Stephanie
AIDS and Behavior 15(2): 407-421
Publication date: 2011
Comparing computer and face-to-face interviewing (PDF)
Population Briefs 16(3)
Publication date: 2011
Day of dialogue on multipurpose prevention technologies: Toward clarity in nomenclature (PDF)
Brady,Martha; McGrory,C.Elizabeth
Meeting notes
Publication date: 2011
Facilitating regulatory approval of multipurpose prevention technologies for sexual and reproductive health (PDF)
Brady,Martha
Brief
Publication date: 2011
Identification of personal lubricants that can cause rectal epithelial cell damage and enhance HIV-1 replication in vitro (abstract) (HTML)
Begay,Othell; Jean-Pierre,Ninochka; Abraham,Ciby J.; Chudolij,Anne; Seidor,Samantha; Rodriguez,Aixa; Ford,Brian E.; Henderson,Marcus; Katz,David; Zydowsky,Thomas M.; Robbiani,Melissa; Fernandez-Romero,Jose A.
AIDS Research and Human Retroviruses 27(9): 1019-1024
Publication date: 2011
The nonnucleoside reverse transcriptase inhibitor MIV-150 in carrageenan gel prevents rectal transmission of simian/human immunodeficiency virus infection in macaques (abstract) (PDF) (HTML)
Singer,Rachel; Derby,Nina R.; Rodriguez,Aixa; Kizima,Larisa; Kenney,Jessica; Aravantinou,Meropi; Chudolij,Anne; Gettie,Agegnehu; Blanchard,James; Lifson,Jeffrey D.; Piatak Jr.,Michael; Fernandez-Romero,Jose A.; Zydowsky,Thomas M.; Robbiani,Melissa
Journal of Virology 85(11): 5504-5512
Publication date: 2011
Vaginal microbicide combination shown effective in monkeys (PDF)
Population Briefs 16(3)
Publication date: 2011
Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators (abstract) (HTML)
Katzen,Lauren L.; Fernandez-Romero,Jose A.; Sarna,Avina; Murugavel,Kailapuri G.; Gawarecki,Daniel; Zydowsky,Thomas M.; Mensch,Barbara S.
Sexually Transmitted Diseases 38(11): 1050-1055
Publication date: 2011
What regulatory guidance exists for multipurpose prevention technologies (MPTs)? A review of key guidance documents and their applicability to MPTs (PDF)
Brady,Martha; Park,Heeyoung
Publication date: 2011
Breakthrough in microbicides development (PDF)
Rutenberg,Naomi; Townsend,John W.
IPPF Medical Bulletin 44(3): 3-4
Publication date: 2010
Expanded safety and acceptability of the candidate vaginal microbicide Carraguard® in South Africa (abstract) (HTML)
The Carraguard Phase II South Africa Study Team
Contraception 82(6): 563-571
Publication date: 2010
The role of ARVs in HIV prevention: Microbicides and PrEP (PDF)
Kalibala,Sam; Littlefield,Sarah A.
GMHC Treatment Issues (December 2010)
Publication date: 2010
"Hope against HIV: Microbicide trials in your community," educational video available in English, French, ki-Swahili, isi-Zulu, and isi-Xhosa (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) (HTML)
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) (HTML)
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) (HTML)
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
Vaginal microbicide adherence biomarkers should be validated--Authors' reply (HTML)
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) (HTML)
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 randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand (abstract) (HTML)
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
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
Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials (abstract) (HTML)
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) (HTML)
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
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
Imvume unolwazi ocwaningweni lokuvimbela igciwane lesandulela ngculaza [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF)
Publication date: 2008
Informed consent in HIV prevention trials: Highlights from an international workshop (PDF)
Publication date: 2008
Microbicide product development (abstract) (HTML)
Maguire,Robin A.
Current Opinion in HIV and AIDS 3(5): 554-557
Publication date: 2008
Microbicides (HTML)
Kaldor,John; Robbiani,Melissa
Current Opinion in HIV and AIDS 3(5)
Publication date: 2008
Microbicides: Chemistry, structure, and strategy (abstract) (HTML)
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) (HTML)
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
Rectal microbicides (abstract) (HTML)
McGowan,Ian; Anton,Peter
Current Opinion in HIV and AIDS 3(5): 593-598
Publication date: 2008
Carrageenan/MIV-150 (PC-815), a combination microbicide (abstract) (HTML)
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) (HTML)
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) (HTML)
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) (HTML)
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
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) (HTML)
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) (HTML)
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) (HTML)
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
Slamming the door on unwanted guests: Why preemptive strikes at the mucosa may be the best strategy against HIV (abstract) (PDF)
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) (PDF) (HTML)
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) (HTML)
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) (HTML)
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) (HTML)
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) (PDF) (HTML)
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
Paving the Path: Preparing for Microbicide Introduction--Report of a Qualitative Study in South Africa [Executive Summary] (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) (HTML)
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) (HTML)
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) (HTML)
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) (HTML)
van de Wijgert,Janneke; Fullem,Andrew; Kelly,Clifton A.; 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) (HTML)
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) (PDF) (HTML)
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) (HTML)
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) (PDF) (HTML)
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) (HTML)
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) (PDF) (HTML)
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 (PDF)
Elias,Christopher J.; Heise,Lori L.
Programs Division Working Paper (no. 6)
Publication date: 1993
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