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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Washington

Collaborator
GlaxoSmithKline
National Institutes of Health (NIH)

Information provided by (Responsible Party)
University of Washington
ClinicalTrials.gov Identifier
NCT00161434

First received: September 8, 2005
Last updated: December 29, 2007
Last Verified: December 2007
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Herpes Simplex
HIV Infections

Drug : valacyclovir
Drug : placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons

Further study details as provided by University of Washington:

Primary Outcome Measures

  • To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: March 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1

Drug: valacyclovir

1 gram daily for 8 weeks

Other Name: Valtrex
Placebo Comparator: 2

Drug: placebo

matching placebo for 8 weeks

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161434

Locations

United States, Washington
Virology Research Clinic
Seattle, Washington, United States, 98122

Sponsors and Collaborators

University of Washington
GlaxoSmithKline
National Institutes of Health (NIH)

Investigators

Principal Investigator: Anna Wald, MD, MPH University of Washington
More Information

More Information


Responsible Party: Anna Wald, MD, MPH, University of Washington  
ClinicalTrials.gov Identifier: NCT00161434   History of Changes  
Other Study ID Numbers: 02-6505-A  
  P01AI030731  
Study First Received: September 8, 2005  
Last Updated: December 29, 2007  

Keywords provided by University of Washington:

HIV-1

Additional relevant MeSH terms:
HIV Infections
Herpes Simplex
Valacyclovir
Acyclovir

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.