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

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. Identifier: NCT00005663
Recruitment Status : Unknown
Verified July 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Herpes Simplex HIV Infections Herpes Genitalis Drug: Valacyclovir hydrochloride Phase 3

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  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
Official Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
Study Start Date : June 1999

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00005663

  Hide Study Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Pacific Oaks Research
Beverly Hills, California, United States, 90211
Kraus Med Partners
Los Angeles, California, United States, 90036
ViRx Inc
San Francisco, California, United States, 94109
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Healthnet Institute
Fort Lauderdale, Florida, United States, 33316
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
Palm Beach Research Ctr
West Palm Beach, Florida, United States, 33409
United States, Indiana
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Advanced Biomedical Research Inc
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States, 28207
Wake County Dept of Health
Raleigh, North Carolina, United States, 27610
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Dr Alvan Fisher
Providence, Rhode Island, United States, 02907
United States, Texas
Baylor College of Medicine / Dept of Medicine
Houston, Texas, United States, 770303498
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23219
United States, Washington
Univ of Washington Virology Research Clinic
Seattle, Washington, United States, 98122
Canada, Alberta
Dr Barbara Romanowski
Edmonton, Alberta, Canada
Canada, Ontario
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Canada, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Centre De Recherche En Infectiologie
Ste Foy, Quebec, Canada
Sponsors and Collaborators
Glaxo Wellcome Identifier: NCT00005663     History of Changes
Other Study ID Numbers: 104C
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2001

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Simplex
Antiviral Agents
Anus Diseases
Herpes Genitalis

Additional relevant MeSH terms:
HIV Infections
Herpes Simplex
Herpes Genitalis
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
Genital Diseases, Male
Genital Diseases, Female
Antiviral Agents
Anti-Infective Agents