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HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Asociación Civil Impacta Salud y Educación, Peru
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00378976
First received: September 19, 2006
Last updated: August 21, 2013
Last verified: August 2013

September 19, 2006
August 21, 2013
August 2003
Not Provided
Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation.
Complete list of historical versions of study NCT00378976 on ClinicalTrials.gov Archive Site
  • Evaluate HSV-2 suppression with decreased plasma HIV RNA levels [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate HSV-2 suppression with decreased plasma HIV RNA levels;
  • Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals;
  • 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.
Not Provided
Not Provided
 
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infection
  • Herpes Simplex
  • Sexually Transmitted Diseases
  • Drug: valacyclovir
    500 mg twice-daily oral
  • Drug: matching placebo
    twice daily as per experimental drug
  • Experimental: 1
    Intervention: Drug: valacyclovir
  • Placebo Comparator: 2
    Intervention: Drug: matching placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2004
Not Provided

Inclusion Criteria:

  • Greater than 18 years old,
  • Documented HIV-1 seropositive,
  • CD4 count greater than 200,
  • Not on HIV antiretroviral therapy,
  • HSV-2 seropositive as determined by Focus EIA (IN >3.5)
  • Not intending to move out of the area for the duration of study participation.
  • Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
  • Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.

Exclusion Criteria:

MSM who meet any of the following criteria are not eligible for this study:

  • Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
  • Planned open label use of acyclovir, valacyclovir, or famciclovir
  • Known medical history of seizures
  • Known renal failure, serum creatinine >2.0mg/dl
  • Hematocrit < 30 %
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00378976
21760-A, AI277S7;AI38858;AI30731
No
Connie Celum, MD, MPH, University of Washington
University of Washington
  • GlaxoSmithKline
  • Asociación Civil Impacta Salud y Educación, Peru
Principal Investigator: Connie Celum, MD, MPH University of Washington
University of Washington
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP