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

Phase 4

Completed

• Conditions: HIV; Herpes

• Registration Number: NCT00362596
• Lead Sponsor: Centers for Disease Control and Prevention

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 Timeline

• Study Start: 2005-01
• Study Completion: 2005-08
• Status Verified: 2006-08
• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-09
• Last Update Submitted: 2006-08-09
• Study First Posted: 2006-08-10
• Last Update Posted: 2006-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

• participants will be HIV and HSV-2 seropositive

Exclusion Criteria

• pregnancy, CD4 count <200, on ART

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

TUC; 🇹🇭 Chiang Rai, Thailand