HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.
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|ClinicalTrials.gov Identifier: NCT00378976|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : August 22, 2013
|First Submitted Date ICMJE||September 19, 2006|
|First Posted Date ICMJE||September 21, 2006|
|Last Update Posted Date||August 22, 2013|
|Study Start Date ICMJE||August 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]|
|Original Primary Outcome Measures ICMJE
||Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation.|
|Change History||Complete list of historical versions of study NCT00378976 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.|
|Official Title ICMJE||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).|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date||July 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
MSM who meet any of the following criteria are not eligible for this study:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Peru|
|Removed Location Countries|
|NCT Number ICMJE||NCT00378976|
|Other Study ID Numbers ICMJE||21760-A
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Connie Celum, MD, MPH, University of Washington|
|Study Sponsor ICMJE||University of Washington|
|PRS Account||University of Washington|
|Verification Date||August 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP