Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.

Inclusion criteria

• HIV negative and agree to be tested for HIV and told their results at all visits during the study
• Aged 16 - 40 years of age
• Have had at least one vaginal intercourse within the last three months
• Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
• Provide locator information to study staff throughout the trial
• Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
• Citizen or permanent resident of South Africa
• Resident for the past year and intends to reside in the catchment area of the site for the next two years
• During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.

Exclusion criteria

• Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
• Within four weeks of last pregnancy outcome at the time of enrolment
• Pap smear at screening is graded as carcinoma.
• Injected illicit drugs in the 12 months prior to screening
• Participating in any other clinical trial/HIV prevention study