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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) HIV Prevention Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00074425 |
The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.
Condition | Intervention | Phase |
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HIV Infections |
Drug: BufferGel Drug: PRO 2000/5 Gel Drug: Placebo gel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women |
Estimated Enrollment: | 3220 |
Study Start Date: | February 2005 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BufferGel
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Drug: BufferGel
Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
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2: Experimental
Pro 2000/5 Gel (P)
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Drug: PRO 2000/5 Gel
Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
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3: Placebo Comparator
Placeo Gel
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Drug: Placebo gel
Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
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4: No Intervention |
Accessible, usable, and effective vaginal microbicides could significantly decrease the spread of HIV. Vaginal microbicides could be used with condoms to prevent HIV infection; they could also be used in situations in which an individual is unable to negotiate condom use. Vaginal microbicides are potentially bidirectional, preventing both male-to-female and female-to-male HIV transmission. This study will evaluate the safety and effectiveness of two vaginal microbicides, BufferGel and PRO 2000/5, in preventing the transmission of HIV. The study will also evaluate the effectiveness of these gels in preventing other common sexually transmitted infections (STIs).
BufferGel is a buffering agent designed to maintain normal vaginal acidity in the presence of ejaculate. Studies have shown that HIV is inactivated below a pH of 4 to 5.8. Carbopol 974, the major nonaqueous component of BufferGel, is commonly used as a gelling or tableting agent and has a well-documented safety record. BufferGel has proven safe and well tolerated in Phase I studies. PRO 2000/5 inhibits viral entry into susceptible cells.
PRO 2000/5 has also been evaluated in Phase I studies and was found to be safe and well tolerated.
Participants in this study will be randomly assigned to receive one of four interventions: BufferGel, PRO 2000/5, placebo gel, or no gel. All participants will receive HIV risk reduction counseling, condoms, and diagnosis and treatment of sexually transmitted diseases. Participants in the three gel arms will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of the product (BufferGel, PRO 2000/5, or placebo gel) intravaginally up to 60 minutes before each vaginal intercourse while in the study.
Participants will be enrolled for approximately 12 to 30 months, depending on when they enter the study. Participants will have two screening study visits and then monthly visits. Monthly study visits may take place at a clinic, the participant's home, or other community site. Monthly visits will include a medical interview; urine testing, including pregnancy testing; HIV and sexually transmitted infection risk reduction counseling; and distribution of study supplies (condoms and gel-filled applicators). Blood collection will occur at selected monthly visits. Four times a year, participants will be seen in the clinic for a more structured medical interview, pelvic exam, and HIV testing. At one of these visits, participants at particular sites who are willing will be asked to complete a behavioral risk assessment. At some visits vaginal fluid swabs will occur. Participants at non-US study sites will be asked for permission for these swabs to be stored for further testing. Assessment interviews will be both face to face and self-reporting.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study.
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
Malawi | |
Malawi College of Medicine, Queen Elizabeth Central Hospital | |
Blantyre, Malawi | |
South Africa | |
Medical Research Council - Hlabisa | |
Hlabisa, South Africa | |
R.K. Khan Hospital | |
Chatsworth, South Africa | |
Tanzania | |
Kilimanjaro Christian Medical Center | |
Moshi, Tanzania | |
Zambia | |
Kamwala Clinic | |
Lusaka, Zambia | |
Zimbabwe | |
Zimbabwe National Family Planning Council | |
Harare, Zimbabwe, 263 | |
Seke South Clinic | |
Harare, Zimbabwe, 263 |
Study Chair: | Salim Abdool Karim, MBChB, PhD | University of KwaZulu-Natal, Centre for the AIDS Programme of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine |
Study Chair: | Irving Hoffman, PA, MPH | School of Medicine, University of North Carolina |
Study Chair: | Lisa Maslankowski, MD | University of Pennsylvania |
Study Chair: | Groesbeck Parham, MD | Centre for Infectious Disease Research in Zambia |
Study Chair: | Nancy Padian, PhD | Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco; AIDS Research Institute |
Study Chair: | Gita Ramjee, PhD | Medical Research Council, HIV Prevention Research Unit |
Study Chair: | Taha Taha, MD | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HPTN 035 |
Study First Received: | December 11, 2003 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00074425 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity Anti-Infective Agents, Local BufferGel |
PRO 2000 Vagina Risk Factors |
Virus Diseases Anti-Infective Agents, Local Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases Anti-Infective Agents, Local HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |