Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

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.

Official Title

Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women.

Conditions

• HIV Infections
• AIDS
• Sexually Transmitted Diseases
• HIV Seroconversion

Study Type

Interventional

Study Design

Prevention, Randomised, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Time to HIV seroconversion during trial participation (evaluated quarterly)

Secondary Outcome Measures:

• Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
• Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated

Study Start

March 2004

Eligibility & Criteria

• Ages Eligible for Study: 16 – 40 years
• Genders Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Total Enrolment

6203

Contact Details

Empilisweni Clinic    
Cape Town
South Africa, 7925

Setshaba Research Clinic
University of Limpopo – Medunsa Campus