HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
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.
Sexually Transmitted Diseases
Drug: Matching Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Mucosal HSV-2 shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
500mg oral twice daily
Other Name: ValtrexDrug: Matching Placebo
500 mg oral twice daily
Other Name: Placebo for Valacyclovir
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.
|Asociacion Civil Impacta Salud y Educacion|
|Principal Investigator:||Connie Celum, MD, MPH||University of Washington|