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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00161434
First received: September 8, 2005
Last updated: December 29, 2007
Last verified: December 2007

September 8, 2005
December 29, 2007
March 2003
June 2006   (final data collection date for primary outcome measure)
To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
To assess the reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.
Complete list of historical versions of study NCT00161434 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  • - 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.
Not Provided
Not Provided
 
A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Herpes Simplex
  • HIV Infections
  • Drug: valacyclovir
    1 gram daily for 8 weeks
    Other Name: Valtrex
  • Drug: placebo
    matching placebo for 8 weeks
  • Experimental: 1
    Intervention: Drug: valacyclovir
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161434
02-6505-A, P01 AI 30731
No
Anna Wald, MD, MPH, University of Washington
University of Washington
  • GlaxoSmithKline
  • National Institutes of Health (NIH)
Principal Investigator: Anna Wald, MD, MPH University of Washington
University of Washington
December 2007

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