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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014