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

Tracking Information

First Received Date ^ICMJE

August 8, 2006

Last Updated Date

August 9, 2006

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00362596 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

HIV
Herpes

Intervention ^ICMJE

Drug: acyclovir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

pregnancy, CD4 count <200, on ART

Gender

Female

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00362596

Responsible Party

Study ID Numbers ^ICMJE

CDC-NCHSTP-4178

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Ministry of Health, Thailand

Investigators ^ICMJE

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

Information Provided By

Centers for Disease Control and Prevention

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP