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

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ClinicalTrials.gov Identifier: NCT00161434
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Herpes Simplex HIV Infections Drug: valacyclovir Drug: placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : March 2003
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: valacyclovir
1 gram daily for 8 weeks
Other Name: Valtrex
Placebo Comparator: 2 Drug: placebo
matching placebo for 8 weeks


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anna Wald, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00161434     History of Changes
Other Study ID Numbers: 02-6505-A
P01AI030731 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007

Keywords provided by University of Washington:
HIV-1

Additional relevant MeSH terms:
HIV Infections
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents