Status:
COMPLETED
Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
Lead Sponsor:
Population Council
Collaborating Sponsors:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Conditions:
HIV Infections
AIDS
Eligibility:
FEMALE
16-40 years
Phase:
PHASE3
Brief 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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
6203 Patients enrolled
Trial Details
Trial ID
NCT00213083
Start Date
April 1 2004
End Date
April 1 2007
Last Update
August 15 2017
Active Locations (3)
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1
Isipingo Clinic
Overport, Durban, South Africa, 4067
2
Empilisweni Clinic
Cape Town, South Africa, 7925
3
Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Medunsa, South Africa, 0204