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

August 8, 2006
August 9, 2006
January 2005
Not Provided
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Same as current
Complete list of historical versions of study NCT00362596 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV
  • Herpes
Drug: acyclovir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
August 2005
Not Provided

Inclusion Criteria:

  • participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

  • pregnancy, CD4 count <200, on ART
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00362596
CDC-NCHSTP-4178
Not Provided
Not Provided
Centers for Disease Control and Prevention
Ministry of Health, Thailand
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
Centers for Disease Control and Prevention
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP