BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
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Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: BufferGel Drug: PRO 2000/5 Gel Drug: Placebo gel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- Safety of BufferGel and 0.5% PRO 2000/5 Gel (P), as assessed by deep epithelial disruption, other genital symptoms, or other systemic symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- HIV infection as measured by seroconversion [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Bacterial vaginosis [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Chlamydia infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Genital ulcer disease [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Gonorrhea infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Herpes simplex virus-2 infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Pregnancy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Syphilis infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Trichomoniasis [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Acceptability of study product [ Time Frame: At Month 3 and study exit ] [ Designated as safety issue: No ]
- Number of behavioral risk assessment questions not answered in self-reported interviews [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Rates of condom use versus gel use [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Establishment of a repository of vaginal swab specimens for long-term storage and future research testing on biomarkers of microbicide safety and effectiveness [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 3101 |
| Study Start Date: | January 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
BufferGel
|
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.
|
|
Experimental: 2
Pro 2000/5 Gel (P)
|
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.
|
|
Placebo Comparator: 3
Placeo Gel
|
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.
|
| No Intervention: 4 |
Detailed Description:
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.
Eligibility| 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:
- HIV uninfected
- Have had sexual intercourse at least once in the 3 months prior to study entry
- Able to provide adequate contact information to study officials for purposes of follow-up
Exclusion Criteria:
- History of adverse reaction to latex
- Nonmedical injection drug use in the 12 months prior to study entry
- Vaginal intercourse more than an average of two times per day in the 2 weeks prior to study entry
- Plan to become pregnant in the 30 months after study entry
- Plan to travel away from the study site for more than 3 consecutive months in the 30 months after study entry
- Plan to relocate away from the study site in the 30 months after study entry
- Participation in another clinical trial of a vaginal product
- Pregnant within 42 days of study entry
- Have a sexually transmitted disease or other reproductive tract infection diagnosed by study staff
- Abnormal pelvic exam indicating deep epithelial disruption
- Condition that, in the opinion of the investigator, may interfere with the study
- Liver or kidney function abnormality of Grade 3 or higher
- Blood or blood clotting abnormality of Grade 4 or higher
Contacts and Locations| United States, Pennsylvania | |
| 3535 Market Street CRS | |
| Philadelphia, Pennsylvania, United States | |
| Malawi | |
| College of Med. JHU CRS | |
| Blantyre, Malawi | |
| University of North Carolina Lilongwe CRS | |
| Lilongwe, Malawi | |
| South Africa | |
| Chatsworth CRS | |
| Chatsworth, KwaZulu-Natal, South Africa | |
| Med. Research Council-Hlabisa | |
| Durban, KwaZulu-Natal, South Africa | |
| Tanzania | |
| Kilimanjaro Christian Medical CRS | |
| Moshi, Tanzania | |
| Zambia | |
| Kamwala Clinic CRS | |
| Lusaka, Zambia | |
| Zimbabwe | |
| Seke South CRS | |
| Chitungwiza, Zimbabwe, 263 | |
| Spilhaus CRS | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00074425 History of Changes |
| Obsolete Identifiers: | NCT00197665 |
| Other Study ID Numbers: | HPTN 035, 10065 |
| Study First Received: | December 11, 2003 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Seronegativity Anti-Infective Agents, Local BufferGel |
PRO 2000 Vagina Risk Factors |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Anti-Infective Agents Anti-Infective Agents, Local Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013
