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

NCT ID: NCT00005663

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30

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.

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.

Conditions

Herpes Simplex; HIV Infections; Herpes Genitalis

Keywords

Herpes Simplex; Antiviral Agents; Anus Diseases; Herpes Genitalis; Recurrence; valacyclovir

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Valacyclovir hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: lead

Locations

East Bay AIDS Ctr

Berkeley, California, United States

Pacific Oaks Research

Beverly Hills, California, United States

Kraus Med Partners

Los Angeles, California, United States

ViRx Inc

San Francisco, California, United States

IDC Research Initiative

Altamonte Springs, Florida, United States

Healthnet Institute

Fort Lauderdale, Florida, United States

Univ of Miami School of Medicine

Miami, Florida, United States

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States

Palm Beach Research Ctr

West Palm Beach, Florida, United States

Indiana Univ School of Medicine / Dept of Infect Dis

Indianapolis, Indiana, United States

Univ of Minnesota

Minneapolis, Minnesota, United States

Advanced Biomedical Research Inc

Hackensack, New Jersey, United States

Nalle Clinic / Clinical Research Dept

Charlotte, North Carolina, United States

Wake County Dept of Health

Raleigh, North Carolina, United States

Westover Heights Clinic

Portland, Oregon, United States

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Dr Alvan Fisher

Providence, Rhode Island, United States

Baylor College of Medicine / Dept of Medicine

Houston, Texas, United States

Richmond AIDS Consortium

Richmond, Virginia, United States

Univ of Washington Virology Research Clinic

Seattle, Washington, United States

Dr Barbara Romanowski

Edmonton, Alberta, Canada

Sunnybrook Health Science Ctr

Toronto, Ontario, Canada

Clinique Medicale L'Actuele

Montreal, Quebec, Canada

Centre De Recherche En Infectiologie

Ste Foy, Quebec, Canada

Countries

United States; Canada

Other Identifiers

HS230018

Identifier Type: -

Identifier Source: secondary_id

104C

Identifier Type: -

Identifier Source: org_study_id