Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
NCT ID: NCT00213083
Last Updated: 2017-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
6203 participants
INTERVENTIONAL
2004-04-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Carraguard (PC-515)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
40 Years
FEMALE
Yes
Sponsors
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United States Agency for International Development (USAID)
FED
Bill and Melinda Gates Foundation
OTHER
Population Council
OTHER
Responsible Party
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Principal Investigators
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Pekka Lahteenmaki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Population Council, Center for Biomedical Research
Locations
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Isipingo Clinic
Overport, Durban, South Africa
Empilisweni Clinic
Cape Town, , South Africa
Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Medunsa, , South Africa
Countries
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References
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Skoler S, Govender S, Altini L, Ahmed K, Waldron D, Myer L, Lahteenmaki P. Risks in the use of an unblinded-control group. J Infect Dis. 2005 Apr 15;191(8):1378-9; author reply 1379-80. doi: 10.1086/427833. No abstract available.
Wallace AR, Teitelbaum A, Wan L, Mulima MG, Guichard L, Skoler S, Vilakazi H, Mapula FS, Rossier J, Govender SN, Lahteenmaki P, Maguire RA, Phillips DM. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception. 2007 Jul;76(1):53-6. doi: 10.1016/j.contraception.2006.10.012. Epub 2007 May 11.
Singh JA, Karim SS, Karim QA, Mlisana K, Williamson C, Gray C, Govender M, Gray A. Enrolling adolescents in research on HIV and other sensitive issues: lessons from South Africa. PLoS Med. 2006 Jul;3(7):e180. doi: 10.1371/journal.pmed.0030180. Epub 2006 Apr 18.
Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Friedland B, Govender S, De Kock A, Cassim N, Palanee T, Dozier G, Maguire R, Lahteenmaki P. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Dec 6;372(9654):1977-87. doi: 10.1016/S0140-6736(08)61842-5.
Related Links
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Official website of the Population Council
Other Identifiers
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Population Council #322
Identifier Type: -
Identifier Source: org_study_id
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