Trial of SAVVY and HIV in Ghana
Overview
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 for the prevention of male-to-female transmission of HIV among women at high risk.
Full Title of Study: “Randomized Controlled Trial of SAVVY and HIV in Ghana”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double
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 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.
Interventions
- Drug: 1.0% C31G SAVVY vaginal gel
Clinical Trial Outcome Measures
Primary Measures
- combined incidence of HIV-1 and HIV-2
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Biosyn
- Collaborator
- FHI 360
- Overall Official(s)
- Leigh Peterson, PhD, Study Chair, FHI 360
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.