NCT00362596

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Herpes

Interventions

Type	Name	Description
DRUG	acyclovir

Timeline

• Start date: 2005-01-01
• Completion: 2005-08-01
• First posted: 2006-08-10
• Last updated: 2006-08-10

Locations

1 site across 1 country: Thailand