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Trial record 12 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT00465205
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : August 22, 2013
Sponsor:
Collaborators:
GlaxoSmithKline
Asociación Civil Impacta Salud y Educación, Peru
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 24, 2007
Last Update Posted Date August 22, 2013
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
Reduction in HIV-1 shedding with suppression of HSV-2 reactivation.
Change History Complete list of historical versions of study NCT00465205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
  • Mucosal HSV-2 shedding [ Time Frame: 18 weeks ]
  • Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Herpes Simplex
  • Sexually Transmitted Diseases
Intervention  ICMJE
  • Drug: Valacyclovir
    500mg oral twice daily
    Other Name: Valtrex
  • Drug: Matching Placebo
    500 mg oral twice daily
    Other Name: Placebo for Valacyclovir
Study Arms  ICMJE Experimental: I
Interventions:
  • Drug: Valacyclovir
  • Drug: Matching Placebo
Publications * 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. doi: 10.1086/593214.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 %
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465205
Other Study ID Numbers  ICMJE 21760-A (2)
AI277S7;AI38858;AI30731
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Celum MD MPH, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • GlaxoSmithKline
  • Asociación Civil Impacta Salud y Educación, Peru
Investigators  ICMJE
Principal Investigator: Connie Celum, MD, MPH 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