Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Council
• Collaborators: Bill and Melinda Gates Foundation; United States Agency for International Development (USAID)
• Treatments: Anti-Infective Agents

Criteria

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