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

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed

Phase 4

Conditions

HIV

Herpes

Treatments

Drug: acyclovir

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00362596

CDC-NCHSTP-4178

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria