We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00362596
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : August 10, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Herpes Drug: acyclovir Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Study Start Date : January 2005
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

Secondary Outcome Measures :
  1. To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
  2. To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
  3. To evaluate the association of genital symptoms and HIV or HSV genital shedding.
  4. To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362596


Locations
Thailand
TUC
Chiang Rai, Thailand
Sponsors and Collaborators
Centers for Disease Control and Prevention
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00362596     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4178
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: August 10, 2006
Last Verified: August 2006

Keywords provided by Centers for Disease Control and Prevention:
Acyclovir
HIV
HSV

Additional relevant MeSH terms:
Acyclovir
Antiviral Agents
Anti-Infective Agents