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Sponsors and Collaborators: |
Harvard School of Public Health University of Washington |
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Information provided by: | Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT00197574 |
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.
Condition | Intervention | Phase |
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Risk for HIV Infection |
Drug: Acyclovir Behavioral: Condom use |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 |
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.
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria: Heterosexual HIV serodiscordant couples. The following criteria apply to either partner:
In addition, the HIV-negative partner must meet the following criteria:
Exclusion Criteria:
-
Contact: Myron Essex, DVM, PhD | 617 432-2334 | messex@hsph.harvard.edu |
Botswana | |
Princess Marina Hospital | Recruiting |
Gabarone, Botswana | |
Contact: Joseph Makhema, MD jmakhema@bhp.org.bw |
Study Chair: | Connie Celum, MD, MPH | University of Washington |
Study ID Numbers: | HSC 11141, Gates Foundation 26269 |
Study First Received: | September 12, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00197574 |
Health Authority: | Botswana: Ministry of Health |
Virus Diseases Sexually Transmitted Diseases, Viral Acyclovir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |