Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

Population Council

Status and phase

Completed

Phase 3

Conditions

Sexually Transmitted Diseases

AIDS

HIV Seroconversion

HIV Infections

Treatments

Drug: Carraguard (PC-515)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00213083

Population Council #322

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,203 patients

Sex

Female

Ages

16 to 40 years old

Volunteers

Accepts Healthy Volunteers

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