A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Information source: Centers for Disease Control and Prevention
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; Herpes
Intervention: acyclovir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Eileen F. Dunne, MD, MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
Sara Whitehead, MD, MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
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.
Clinical Details
Official title: A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- participants will be HIV and HSV-2 seropositive
Exclusion Criteria:
- pregnancy, CD4 count <200, on ART
Locations and Contacts
TUC, Chiang Rai, Thailand
Additional Information
Starting date: January 2005
Ending date: August 2005
Last updated: August 9, 2006
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