HIV Infection Clinical Trial
Official title:
Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
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.
Herpes simplex virus type-2 (HSV-2) is the primary cause of genital ulcers and one of the
most prevalent sexually transmitted diseases worldwide. Consistently, over 30 studies have
found HSV-2 infection to be a risk factor for HIV acquisition with an overall relative risk
of 2.1 in the studies that demonstrated HSV-2 preceded HIV infection. A recent study of
HIV-discordant couples from Rakai, Uganda, has shown that at all levels of HIV viral load in
the HIV-positive partner, HSV-2 infection in the susceptible partner increased the
per-contact risk of acquisition of HIV five-fold, and GUD in the HIV-source partner increased
the per-contact risk of HIV transmission five-fold. As strong as these epidemiological data
are, an intervention trial is required to define the clinical and public health significance
of these findings.
This trial will directly answer the extent to which HSV-2 infection increases infectiousness
of HIV/HSV-2 co-infected persons and the relative reduction in HIV transmission among HSV-2
seropositive persons treated with daily suppressive antiviral therapy. Acyclovir has an
acceptable safety profile for widespread STD treatment and is inexpensive, well-tolerated,
and episodic and long-term suppressive therapy has not been associated with increased
acyclovir resistance. Given high HSV-2 seroprevalence in HIV-infected persons (70-80%) and
high HIV incidence in populations with high prevalence of HSV-2 infection worldwide, this
approach could have great public health importance by providing a safe, acceptable, and
cost-effective method to reduce HIV transmission among HIV-infected persons who are also
HSV-2 seropositive.
Sites that have enrolled couples in this study include: Johannesburg (2 sites) and Cape Town,
South Africa; Gaborone, Botswana; Kitwe/Ndola and Lusaka, Zambia; Nairobi, Kisumu, Eldoret
and Thika, Kenya; Moshi, Tanzania; Kampala, Uganda; and Kigali, Rwanda.
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