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
  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
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

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 April 23, 2014