Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

Summary

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.

Timeline

Start

2004-04

Primary completion

2007-04

Completion

2007-04

Outcome

Missed primary endpoint

paper with no significant difference in the distribution of time to seroconversion (p=0.30). PMID 19059048 ↗

paper INTERPRETATION: This study did not show Carraguard's efficacy in prevention of vaginal transmission of HIV. PMID 19059048 ↗

Publications

• Background 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.
• Background 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.
• Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carraguard	Other / unclassified	—	Other

Indications