Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Washington GlaxoSmithKline Asociacion Civil Impacta Salud y Educacion |
---|---|
Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00378976 |
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 | Intervention | Phase |
---|---|---|
HIV Infection Herpes Simplex Sexually Transmitted Diseases |
Drug: valacyclovir Drug: matching placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
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). |
Enrollment: | 20 |
Study Start Date: | August 2003 |
Study Completion Date: | July 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: valacyclovir
500 mg twice-daily oral
|
2: Placebo Comparator |
Drug: matching placebo
twice daily as per experimental drug
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
MSM who meet any of the following criteria are not eligible for this study:
Peru | |
Asociacion Civil Impacta Salud y Educacion | |
Lima, Peru |
Principal Investigator: | Connie Celum, MD, MPH | University of Washington |
Responsible Party: | University of Washington ( Connie Celum, MD, MPH ) |
Study ID Numbers: | 02-3200-A-05, AI277S7;AI38858;AI30731 |
Study First Received: | September 19, 2006 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00378976 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV infection HIV shedding HSV suppression Co-infected |
MSM Reactivation Valacyclovir |
Herpes Simplex Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Genital Diseases, Male Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections |
Valacyclovir Genital Diseases, Female Virus Diseases Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Genital Diseases, Female Valacyclovir Therapeutic Uses Retroviridae Infections Herpes Simplex RNA Virus Infections Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome |
Genital Diseases, Male Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |