A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients

June 23, 2005 updated by: Glaxo Wellcome

An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects

The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Dr Barbara Romanowski
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Ste Foy, Quebec, Canada
        • Centre De Recherche En Infectiologie
  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Los Angeles, California, United States, 90036
        • Kraus Med Partners
      • San Francisco, California, United States, 94109
        • ViRx Inc
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Fort Lauderdale, Florida, United States, 33316
        • Healthnet Institute
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ School of Medicine / Dept of Infect Dis
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Advanced Biomedical Research Inc
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic / Clinical Research Dept
      • Raleigh, North Carolina, United States, 27610
        • Wake County Dept of Health
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Rhode Island
      • Providence, Rhode Island, United States, 02907
        • Dr Alvan Fisher
    • Texas
      • Houston, Texas, United States, 770303498
        • Baylor College of Medicine / Dept of Medicine
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
    • Washington
      • Seattle, Washington, United States, 98122
        • Univ of Washington Virology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have herpes simplex virus (HSV) 2.
  • Have received combination anti-HIV therapy for at least 2 months before entering the study.
  • Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
  • Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have blood vessel disease.
  • Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
  • Are unable to take medications by mouth.
  • Have non-healed sores on the anus or genitals at beginning of study.
  • Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
  • Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
  • Have kidney or liver problems.
  • Are pregnant or breast-feeding.
  • Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Study Registration Dates

First Submitted

May 11, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104C
  • HS230018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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