A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00362596
First received: August 8, 2006
Last updated: August 9, 2006
Last verified: August 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Herpes |
Drug: acyclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Secondary Outcome 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.
| Estimated Enrollment: | 67 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | August 2005 |
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| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- participants will be HIV and HSV-2 seropositive
Exclusion Criteria:
- pregnancy, CD4 count <200, on ART
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362596
Locations
| Thailand | |
| TUC | |
| Chiang Rai, Thailand | |
Sponsors and Collaborators
Ministry of Health, Thailand
Investigators
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00362596 History of Changes |
| Other Study ID Numbers: | CDC-NCHSTP-4178 |
| Study First Received: | August 8, 2006 |
| Last Updated: | August 9, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
Acyclovir HIV HSV |
Additional relevant MeSH terms:
|
Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013