Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
The University of Washington has received funding to conduct a proof-of-concept trial to
assess the impact of suppression of genital herpes on HIV infectiousness. This study (the
Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the
HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the
efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent
transmission to his/her HIV negative partner(s). This randomized, double-blind,
placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2
suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom
the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis
is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of
daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant
couples among whom the HIV-infected partner is HSV-2 positive.
Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the
HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited;
participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo
arm is assumed.
The first study site began enrolling participants on 17 November 2005. As of September 2006,
14 sites in Eastern and Southern Africa had participated in recruiting the 2300
HIV-discordant couples enrolled to date.