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

This study is currently recruiting participants.

Verified by Harvard School of Public Health, September 2005

First Received: September 12, 2005 Last Updated: December 12, 2005 History of Changes

Sponsor:	Harvard School of Public Health
Collaborator:	University of Washington
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197574

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

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.

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197574

Contacts

Contact: Myron Essex, DVM, PhD

617 432-2334

messex@hsph.harvard.edu

Locations

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

Sponsors and Collaborators

Harvard School of Public Health

University of Washington

Investigators

Study Chair:

Connie Celum, MD, MPH

University of Washington

More Information

No publications provided

Study ID Numbers:	HSC 11141, Gates Foundation 26269
Study First Received:	September 12, 2005
Last Updated:	December 12, 2005
ClinicalTrials.gov Identifier:	NCT00197574 History of Changes
Health Authority:	Botswana: Ministry of Health

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Acyclovir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010