HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
|ClinicalTrials.gov Identifier: NCT00465205|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : August 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Herpes Simplex Sexually Transmitted Diseases||Drug: Valacyclovir Drug: Matching Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2007|
500mg oral twice daily
Other Name: Valtrex
Drug: Matching Placebo
500 mg oral twice daily
Other Name: Placebo for Valacyclovir
- Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ]
- Mucosal HSV-2 shedding [ Time Frame: 18 weeks ]
- Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ Time Frame: 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465205
|Asociacion Civil Impacta Salud y Educacion|
|Principal Investigator:||Connie Celum, MD, MPH||University of Washington|