Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
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ClinicalTrials.gov Identifier: NCT00213083
Recruitment Status :
First Posted : September 21, 2005
Last Update Posted : August 15, 2017
United States Agency for International Development (USAID)
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
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Ages Eligible for Study:
16 Years to 40 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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