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

Primary Purpose

Herpes Simplex, HIV Infections, Herpes Genitalis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valacyclovir hydrochloride
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex, Antiviral Agents, Anus Diseases, Herpes Genitalis, Recurrence, valacyclovir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Bay AIDS Ctr
  • Pacific Oaks Research
  • Kraus Med Partners
  • ViRx Inc
  • IDC Research Initiative
  • Healthnet Institute
  • Univ of Miami School of Medicine
  • Treasure Coast Infectious Disease Consultants
  • Palm Beach Research Ctr
  • Indiana Univ School of Medicine / Dept of Infect Dis
  • Univ of Minnesota
  • Advanced Biomedical Research Inc
  • Nalle Clinic / Clinical Research Dept
  • Wake County Dept of Health
  • Westover Heights Clinic
  • Philadelphia FIGHT
  • Dr Alvan Fisher
  • Baylor College of Medicine / Dept of Medicine
  • Richmond AIDS Consortium
  • Univ of Washington Virology Research Clinic
  • Dr Barbara Romanowski
  • Sunnybrook Health Science Ctr
  • Clinique Medicale L'Actuele
  • Centre De Recherche En Infectiologie

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 11, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00005663
Brief Title
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections, Herpes Genitalis
Keywords
Herpes Simplex, Antiviral Agents, Anus Diseases, Herpes Genitalis, Recurrence, valacyclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valacyclovir hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Kraus Med Partners
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Healthnet Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Palm Beach Research Ctr
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Indiana Univ School of Medicine / Dept of Infect Dis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Advanced Biomedical Research Inc
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Nalle Clinic / Clinical Research Dept
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake County Dept of Health
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Dr Alvan Fisher
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02907
Country
United States
Facility Name
Baylor College of Medicine / Dept of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
770303498
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Univ of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Dr Barbara Romanowski
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre De Recherche En Infectiologie
City
Ste Foy
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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

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