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

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:

Allocation: Randomized

Control: Placebo Control

Intervention Model: Parallel Assignment

Masking: Double-Blind

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


ClinicalTrials.gov Identifier:

NCT00197574 History of Changes

Other Study ID Numbers:

HSC 11141, Gates Foundation 26269

Study First Received:

September 12, 2005

Last Updated:

December 12, 2005

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

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 June 15, 2010 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:

Allocation: Randomized

Control: Placebo Control

Intervention Model: Parallel Assignment

Masking: Double-Blind

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


ClinicalTrials.gov Identifier:

NCT00197574 History of Changes

Other Study ID Numbers:

HSC 11141, Gates Foundation 26269

Study First Received:

September 12, 2005

Last Updated:

December 12, 2005

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

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 June 15, 2010