Phase III Trial of HSV-2 Suppression in Sero-Discordant Couples and Substudy on Role of TNF-a in HIV-1 Transmission

Condition(s) targeted: Risk for HIV Infection

Intervention: Acyclovir (Drug); Condom use (Behavioral)

Phase: Phase 3

Status: Recruiting

Sponsored by: Harvard School of Public Health

Official(s) and/or principal investigator(s):
Connie Celum, MD, MPH, Study Chair, Affiliation: University of Washington

Overall contact:
Myron Essex, DVM, PhD, Phone: 617 432-2334, Email: messex@hsph.harvard.edu

This study will test the hypothesis that treating HSV-2 infection in the HIV-infected partner of a heterosexual couple (meaning that one partner has HIV and the other does not) will reduce the chances that he or she will transmit the HIV virus to the uninfected partner.

Official title: Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV Sero-Discordant Couples and Substudy: Role of TNF-a in HIV-1 Transmission in African Adults

Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Detailed description: This is a proof of concept study taht Suppression of Herpes Simpleax Virus Type 2 (HSV-2), the virus that cuases genital herpes, among HIV-infected persons reduces the transmission risk of passing on HIV to the HIV-uninfected partner during sexual intercourse. The Study is conducted among HIV-sero-discordant heterosexual couples in the Gabarone, Botswana region. A subset of samples will be analyzed for a study on the role of TNF-alpha in HIV-1 transmission. The goals of the substudy are to determine whether genotypic and phenotypic characteristics of HIV-1 subtypes are linked to levels of viral activation by TNF-alpha protein in virtol, whether genital viral RNA and DNA levels correlate with NF-KappaB copy number of the viral LTR and/or the viral subtype; and several other measures. Other sites include Tanzania and Kenya.

Minimum age: 21 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Heterosexual HIV serodiscordant couples. The following criteria apply to either partner:

- Of legal age in Botswana to provide independent informed consent

- Willing to provide written informed consent to be screened and take part

- Willing to provide adequate locator information Potential HIV-infected partners must

also meet the following specific criteria

- Be HIV+ based on two different + rapid HIV tests confirmed by + ELISA

- Be HSV-2 seropositive based on the Focus HSV-2 EIA with an index ratio of at least

3. 5

- Have had vaginal intercourse with the HIV-uninfected study partner at least once per

month for the previous 3 months and plan to maintain his or her relationship with the uninfected partner for at least one year post-enrollment

- Have a CD4 T-cell count of at least 250 cells/mm3 of blood and be free of any AIDS

defining illness at time of enrollment

In addition, the HIV-negative partner must meet the following criteria:

- Be part of a heterosexual couple in whih their partner meets the above inclusion

criteria for HIV-positive partner

- Be HIV-negative by two different rapid HIV EIA tests

- Have had vaginal intercourse with the HIV+ partner at least once per month for the

previous three months and plan to have a sexual relationship only iw th his/her HIV-infected partner for the next one year

Exclusion Criteria:

-

Myron Essex, DVM, PhD, Phone: 617 432-2334, Email: messex@hsph.harvard.edu

Princess Marina Hospital, Gabarone, Botswana; Recruiting
Joseph Makhema, MD, Email: jmakhema@bhp.org.bw

Last updated: December 12, 2005