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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362596

Enrollment

Registered

2006-08-10

Start date

2005-01-31

Completion date

2005-08-31

Last updated

2006-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes, HIV

Keywords

Acyclovir, HIV, HSV

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.

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.

Interventions

DRUGacyclovir

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Inclusion criteria

* participants will be HIV and HSV-2 seropositive

Exclusion criteria

* pregnancy, CD4 count \<200, on ART

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.	—

Secondary

Measure	Time frame
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.	—

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026