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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005663
• Other study ID #: 104C
• Secondary ID: HS230018
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 11, 2000
• Last updated: June 23, 2005
• Start date: June 1999

Study information

• Verified date: July 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Genitalis
• Herpes Simplex
• HIV Infections

Intervention

Drug:
• Valacyclovir hydrochloride

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada,