A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
1 other identifier
interventional
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv
Started Jan 2005
Shorter than P25 for phase_4 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedAugust 10, 2006
August 1, 2006
August 8, 2006
August 9, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Secondary Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- participants will be HIV and HSV-2 seropositive
You may not qualify if:
- pregnancy, CD4 count \<200, on ART
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TUC
Chiang Rai, Changwat Chiang Rai, Thailand
Related Publications (1)
Dunne EF, Whitehead S, Sternberg M, Thepamnuay S, Leelawiwat W, McNicholl JM, Sumanapun S, Tappero JW, Siriprapasiri T, Markowitz L. Suppressive acyclovir therapy reduces HIV cervicovaginal shedding in HIV- and HSV-2-infected women, Chiang Rai, Thailand. J Acquir Immune Defic Syndr. 2008 Sep 1;49(1):77-83. doi: 10.1097/QAI.0b013e3181831832.
PMID: 18667923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen F. Dunne, MD, MPH
Centers for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
Sara Whitehead, MD, MPH
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 10, 2006
Study Start
January 1, 2005
Study Completion
August 1, 2005
Last Updated
August 10, 2006
Record last verified: 2006-08