A Randomized, Double-blind, Placebo-controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon
The main objective is to assess the reduction in genital HIV-1 shedding associated with
daily acyclovir for suppression of HSV-2 reactivation.
All patients will be treated with the usual antibiotic treatment for any sexually
transmitted infections that are diagnosed during the study. In addition, half will receive
acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study
medication will reverse in the second 8 weeks of the study. The patients will attend the
clinic 3 times per week during the first and the last 8 weeks of the study and once every
week during the washout period in the middle of the study - for a total of 18 weeks per
participant. At each visit genital and oral samples will be collected. A blood sample will
also be collected. For women participants, pregnancy test will be performed. The clinic
will provide both pre- and post-HIV test counseling.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
HSV and HIV viral shedding
18 weeks
No
Francois-Xavier Mbopi-Keou, M.Sc, PhD
Principal Investigator
Institute for the Development of Africa
United States: Institutional Review Board
IR File 5687
NCT00209313
March 2005
April 2007
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