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 Details — Status: Completed

Administrative data

• NCT number: NCT00362596
• Other study ID #: CDC-NCHSTP-4178
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2006
• Last updated: August 9, 2006
• Start date: January 2005
• Est. completion date: August 2005

Study information

• Verified date: August 2006
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

• pregnancy, CD4 count <200, on ART

Study Design

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

Related Conditions & MeSH terms

• Herpes
• HIV

Intervention

Drug:
• acyclovir

Locations

Country	Name	City	State
Thailand	TUC	Chiang Rai

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Secondary	To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
Secondary	To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
Secondary	To evaluate the association of genital symptoms and HIV or HSV genital shedding.
Secondary	To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.