A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex; HIV Infections; Herpes Genitalis
Intervention: Valacyclovir hydrochloride (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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 design: Treatment, Double-Blind, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Dr Barbara Romanowski, Edmonton, Alberta, Canada
ViRx Inc, San Francisco, California 94109, United States
Kraus Med Partners, Los Angeles, California 90036, United States
Pacific Oaks Research, Beverly Hills, California 90211, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Palm Beach Research Ctr, West Palm Beach, Florida 33409, United States
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States
Healthnet Institute, Fort Lauderdale, Florida 33316, United States
Indiana Univ School of Medicine / Dept of Infect Dis, Indianapolis, Indiana 46202, United States
Univ of Minnesota, Minneapolis, Minnesota 55455, United States
Advanced Biomedical Research Inc, Hackensack, New Jersey 07601, United States
Wake County Dept of Health, Raleigh, North Carolina 27610, United States
Nalle Clinic / Clinical Research Dept, Charlotte, North Carolina 28207, United States
Sunnybrook Health Science Ctr, Toronto, Ontario, Canada
Westover Heights Clinic, Portland, Oregon 97210, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Clinique Medicale L'Actuele, Montreal, Quebec, Canada
Centre De Recherche En Infectiologie, Ste Foy, Quebec, Canada
Dr Alvan Fisher, Providence, Rhode Island 02907, United States
Baylor College of Medicine / Dept of Medicine, Houston, Texas 770303498, United States
Richmond AIDS Consortium, Richmond, Virginia 23219, United States
Univ of Washington Virology Research Clinic, Seattle, Washington 98122, United States
Additional Information
Starting date: June 1999
Last updated: June 23, 2005
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