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

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment

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.

Intervention(s) in this Clinical Trial

• Drug: acyclovir

Primary Measures

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

Secondary Measures

• 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.

Inclusion Criteria:

• participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

• pregnancy, CD4 count <200, on ART

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 49 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centers for Disease Control and Prevention

Overall Clinical Trial Officials and Contacts

Eileen F. Dunne, MD, MPH Principal Investigator Centers for Disease Control and Prevention  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362596

Study ID Number: CDC-NCHSTP-4178

ClinicalTrials.gov Identifier: NCT00362596

Health Authority: United States: Federal Government