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NCT Number: NCT00362596

A Randomized Controlled Trial of Acyclovir 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.

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Key information

Conditions

HIV DNA Virus Infections Herpes Herpes Simplex Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

TUC

Chiang Rai, Changwat Chiang Rai, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants will be HIV and HSV-2 seropositive

Exclusion criteria

  • pregnancy, CD4 count <200, on ART

Treatment and study plan

Acyclovir

Drug

Primary outcomes

  1. To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Aug 10, 2006
Registry last updated
Aug 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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