A Randomized Controlled Trial of Acyclovir 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...
Brief Summary
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: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: acyclovir
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Centers for Disease Control and Prevention U.S. Fed
Overall Clinical Trial Officials and Contacts
Eileen F. Dunne, MD, MPH Principal Investigator Centers for Disease Control and Prevention
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00362596
