Status:
UNKNOWN
Trial of SAVVY Vaginal Gel and HIV in Nigeria
Lead Sponsor:
Biosyn
Collaborating Sponsors:
FHI 360
United States Agency for International Development (USAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel f...
Detailed Description
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effe...
Eligibility Criteria
Inclusion
- 18 to 35 year old women
- HIV negative
- More than one sexual partner in past 3 months
- Average 3 coital acts per week
- Willing to use vaginal gel and condoms for 12 months
Exclusion
- HIV positive
- Pregnant
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
2142 Patients enrolled
Trial Details
Trial ID
NCT00130078
Start Date
September 1 2004
Last Update
September 26 2005
Active Locations (2)
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1
Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan
Ibadan, Nigeria
2
Nigerian Institute of Medical Research
Lagos, Nigeria