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.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.