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| Descriptive Information Fields | |||||||||||||||||||||||||||||
| Brief Title † | BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women | ||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | 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 ] |
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| Condition † | HIV Infections | ||||||||||||||||||||||||||||
| Intervention † | Drug: BufferGel Drug: PRO 2000/5 Gel Drug: Placebo gel |
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| MEDLINE PMIDs | 17453597, 11170957, 11176265, 11984446, 12869836, 12556685, 14754390 | ||||||||||||||||||||||||||||
| Links | Click here for more information on BufferGel ![]() Click here for more information on PRO 2000/5  ![]() Haga clic aquí para ver información sobre este ensayo clínico en español.  ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||||||||||
| Recruitment Status † | Active, not recruiting | ||||||||||||||||||||||||||||
| Enrollment † | 3220 | ||||||||||||||||||||||||||||
| Start Date † | February 2005 | ||||||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||||||
| Eligibility Criteria † | Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||||||
| Contacts †† | |||||||||||||||||||||||||||||
| Location Countries † | United States, Malawi, South Africa, Tanzania, Zambia, Zimbabwe | ||||||||||||||||||||||||||||
| Administrative Information Fields | |||||||||||||||||||||||||||||
| NCT ID † | NCT00074425 | ||||||||||||||||||||||||||||
| Organization ID | HPTN 035 | ||||||||||||||||||||||||||||
| Secondary IDs †† | |||||||||||||||||||||||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||||||||||
| Collaborators †† | 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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| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||||||||||
| Verification Date | March 2008 | ||||||||||||||||||||||||||||
| First Received Date † | December 11, 2003 | ||||||||||||||||||||||||||||
| Last Updated Date | September 11, 2008 | ||||||||||||||||||||||||||||