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Clinical Trials/NCT00129532
NCT00129532
Unknown
Phase 3

Randomized Controlled Trial of SAVVY and HIV in Ghana

Biosyn2 sites in 1 country2,142 target enrollmentJanuary 2004
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ConditionsHIV Infections
Drugs1.0% C31G SAVVY vaginal gel

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Biosyn
Enrollment
2142
Locations
2
Primary Endpoint
combined incidence of HIV-1 and HIV-2
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 for the prevention of male-to-female transmission of HIV among women at high risk.

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Biosyn

Eligibility Criteria

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

Outcomes

Primary Outcomes

combined incidence of HIV-1 and HIV-2

Study Sites (2)

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