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HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Asociación Civil Impacta Salud y Educación, Peru
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00465205
First received: April 23, 2007
Last updated: August 21, 2013
Last verified: August 2013

April 23, 2007
August 21, 2013
January 2005
December 2005   (final data collection date for primary outcome measure)
Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Reduction in HIV-1 shedding with suppression of HSV-2 reactivation.
Complete list of historical versions of study NCT00465205 on ClinicalTrials.gov Archive Site
  • Mucosal HSV-2 shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ 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 with respect to HSV-1 and HSV-2 reactivation;
  • Determine HSV-2 suppression and HIV replication.
Not Provided
Not Provided
 
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
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

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.

Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

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 Infections
  • Herpes Simplex
  • Sexually Transmitted Diseases
  • Drug: Valacyclovir
    500mg oral twice daily
    Other Name: Valtrex
  • Drug: Matching Placebo
    500 mg oral twice daily
    Other Name: Placebo for Valacyclovir
Experimental: I
Interventions:
  • Drug: Valacyclovir
  • Drug: Matching Placebo
Baeten JM, Strick LB, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Magaret A, Wald A, Corey L, Celum C. Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial. J Infect Dis. 2008 Dec 15;198(12):1804-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Greater than 18 years old woman,
  • 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:

Women 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 %
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00465205
21760-A (2), 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