HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.
|ClinicalTrials.gov Identifier: NCT00378976|
Recruitment Status : Completed
First Posted : September 21, 2006
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 that HSV is an important cofactor in HIV transmission.
The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation.
This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Herpes Simplex Sexually Transmitted Diseases||Drug: valacyclovir Drug: matching placebo||Phase 3|
Herpes simplex virus type 2 (HSV-2) is common among HIV infected persons. HSV-2 reactivation is associated with increased plasma and genital HIV-1 levels, and in vitro, HSV-2 upregulates HIV transcription.
The trial assessed whether HSV-2 suppression reduces rectal and plasma HIV-1 levels in HIV-1, HSV-2 co-infected men who have sex with men (MSM).
Conducted in Lima Peru, 20 antiretroviral naive HIV-1 and HSV-2 seropositive MSM with CD4 >200 were randomly assigned to receive valacyclovir 500 mg bid or placebo for 8 weeks, than a 2 week washout period, followed by the alternative regimen for 8 weeks. Men collected daily home anogenital swabs for HSV DNA PCR, had three weekly anoscopy procedures for collection of rectal mucosal secretions for HIV-1 RNA, HSV DNA, and weekly plasma HIV-1 RNA by PCR. Outcomes were plasma and rectal HIV-1 levels by study arm.
|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 Valacyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Men Who Have Sex With Men (MSM).|
|Study Start Date :||August 2003|
|Study Completion Date :||July 2004|
500 mg twice-daily oral
|Placebo Comparator: 2||
Drug: matching placebo
twice daily as per experimental drug
- Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]
- Evaluate HSV-2 suppression with decreased plasma HIV RNA levels [ Time Frame: 18 weeks ]
- Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals [ Time Frame: 18 weeks ]
- Determine the temporal pattern of HIV shedding in the rectum, pharynx and semen with respect to mucosal HSV-1 and HSV-2 reactivation; Determine HSV-2 suppression and HIV replication within rectal mucosa. [ Time Frame: 18 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378976
|Asociacion Civil Impacta Salud y Educacion|
|Principal Investigator:||Connie Celum, MD, MPH||University of Washington|