NCT00465205

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• HIV Infections
• Herpes Simplex
• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DRUG	Valacyclovir	500mg oral twice daily
DRUG	Matching Placebo	500 mg oral twice daily

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-12-01
• Completion: 2007-12-01
• First posted: 2007-04-24
• Last updated: 2013-08-22

Locations

1 site across 1 country: Peru