Title
Trial of SAVVY and HIV in Ghana
Randomized Controlled Trial of SAVVY and HIV in Ghana
Phase
Phase 3Lead Sponsor
BiosynStudy Type
InterventionalStatus
Unknown statusIndication/Condition
HIV InfectionsIntervention/Treatment
Dimethylglycine ...Study Participants
2142Heterosexual 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 for the prevention of male-to-female transmission of HIV among women at high risk.
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 effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.
Inclusion Criteria: 18 to 35 year old women HIV negative More than one sexual partner in past 3 months Average of 3 coital acts per week Willing to use vaginal gel and condoms for 12 months Exclusion Criteria: HIV positive Pregnant