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

HIV Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00362596
Study type Interventional
Source Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 4
Start date January 2005
Completion date August 2005
View Details
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