Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, AIDS, Sexually Transmitted Diseases, HIV Seroconversion

Intervention / Treatment
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* Drug: Carraguard (PC-515)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carraguard (PC-515)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to HIV seroconversion during trial participation (evaluated quarterly) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbicide, HIV, AIDS, STIs, STDs, Efficacy, HSV, Women, South Africa, seroconversion, condom, safe-sex, vaginal intercourse, prevention, HIV Seronegativity