A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	Ministry of Health, Thailand
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00362596

Purpose

Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.

Condition	Intervention	Phase
HIV Herpes	Drug: acyclovir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

Secondary Outcome Measures:

To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
To evaluate the association of genital symptoms and HIV or HSV genital shedding.
To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Estimated Enrollment:	67
Study Start Date:	January 2005
Estimated Study Completion Date:	August 2005

Detailed Description:

65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics, family planning clinics, postnatal clinics, community based organizations and community outreach in Chiang Rai, Thailand.

Our study objectives are:

To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
To evaluate the association of genital symptoms and HIV or HSV genital shedding.
To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

pregnancy, CD4 count <200, on ART

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362596

Locations

Thailand
TUC
Chiang Rai, Thailand

Sponsors and Collaborators

Centers for Disease Control and Prevention

Ministry of Health, Thailand

Investigators

Principal Investigator:	Eileen F. Dunne, MD, MPH	Centers for Disease Control and Prevention
Principal Investigator:	Sara Whitehead, MD, MPH	Centers for Disease Control and Prevention

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00362596 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-4178
Study First Received:	August 8, 2006
Last Updated:	August 9, 2006
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Acyclovir
HIV
HSV

Additional relevant MeSH terms:

Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012