Trial of SAVVY and HIV in Ghana

biosyn Arzneimittel

Status and phase: Unknown; Phase 3

Conditions: HIV Infections

Treatments: Drug: 1.0% C31G SAVVY vaginal gel

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT00129532

9779

Details and patient eligibility

About

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 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.

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind