HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Study Overview
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Brief Summary
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Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission. The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation. This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Detailed Description
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Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

Official Title
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A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons

Conditions
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HIV Infections, Herpes Simplex, Sexually Transmitted Diseases

Intervention / Treatment
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* Drug: Valacyclovir
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years old woman, Documented HIV-1 seropositive, CD4 count greater than 200, Not on HIV antiretroviral therapy, HSV-2 seropositive as determined by Focus EIA (IN >3.5) Not intending to move out of the area for the duration of study participation. Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule. Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment. Exclusion Criteria: Women who meet any of the following criteria are not eligible for this study: Known history of adverse reaction to valacyclovir, acyclovir or famciclovir; Planned open label use of acyclovir, valacyclovir, or famciclovir Known medical history of seizures Known renal failure, serum creatinine >2.0mg/dl Hematocrit < 30 %

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Valacyclovir<br>* 500mg oral twice daily<br>* Other names: Valtrex;Drug: Matching Placebo<br>* 500 mg oral twice daily<br>* Other names: Placebo for Valacyclovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV-1 levels and HIV-1 mucosal shedding |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal HSV-2 shedding |  | 18 weeks | 
| Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; |  | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Co-infected, HIV infection, HIV Shedding, HSV suppression, Women, Reactivation, Valacyclovir, Treatment Naive