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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Herpes

Intervention / Treatment
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* Drug: acyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants will be HIV and HSV-2 seropositive Exclusion Criteria: pregnancy, CD4 count <200, on ART

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acyclovir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acyclovir, HIV, HSV