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A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161434
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2008
Sponsor:
Collaborators:
GlaxoSmithKline
National Institutes of Health (NIH)
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 10, 2008
Study Start Date  ICMJE March 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To assess the reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
To quantify increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation. To determine reduction in systemic HIV RNA during valacyclovir therapy. To evaluate reduction in inflammatory cells and HIV replication. [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • - To quantify the increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation.
  • - To determine the reduction in systemic HIV RNA during valacyclovir therapy.
  • - To evaluate the reduction in inflammatory cells and HIV replication within the rectal mucosa by rectal biopsy during valacyclovir therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons
Brief Summary The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.
Detailed Description

Sexually transmitted diseases and genital ulcer disease (GUD) contribute significantly to the spread of HIV, as their presence is associated with higher rates of HIV acquisition in susceptible individuals. Herpes simplex virus-2 (HSV-2) is a major cause of GUD in developed and developing countries.

The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.

This study is a randomized, double-blind, placebo-controlled, crossover trial. Sixty men who have sex with men (MSM) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. After a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks.

At screening, informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination. At enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. Following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. Participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Herpes Simplex
  • HIV Infections
Intervention  ICMJE
  • Drug: valacyclovir
    1 gram daily for 8 weeks
    Other Name: Valtrex
  • Drug: placebo
    matching placebo for 8 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: valacyclovir
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications * Not Provided

*   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: September 8, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV seropositive and HSV-2 seropositive
  • MSM (men having sex with men)
  • 18 years old or older

Exclusion Criteria:

  • Known history of adverse reaction to acyclovir or valacyclovir
  • Planned open label use of acyclovir, valacyclovir or famciclovir
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161434
Other Study ID Numbers  ICMJE 02-6505-A
P01AI030731 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Wald, MD, MPH, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • GlaxoSmithKline
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Anna Wald, MD, MPH University of Washington
PRS Account University of Washington
Verification Date December 2007

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