A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems

June 23, 2005 updated by: Glaxo Wellcome

A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients

To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Simon - Williamson Clinic
      • Birmingham, Alabama, United States, 35234
        • SORRA / NC Research Ctr
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Univ of Arizona / Univ Med Ctr
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
      • Sunnyvale, California, United States, 94086
        • Sunnyvale Med Clinic
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Clinical Research Consultants
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Med Associates Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington Univ
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • New Mexico Med Group
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Jordon Diagnostics and Research Inc
      • Wilmington, North Carolina, United States, 28401
        • Hanover Med Specialists
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Research Group
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Med Ctr
      • Providence, Rhode Island, United States, 02909
        • Silver Lake Med Inc
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Med Ctr
    • Texas
      • Dallas, Texas, United States, 75219
        • N Texas Ctr for AIDS & Clin Rsch
      • Houston, Texas, United States, 77054
        • MacGregor Med Association
      • Nassau Bay, Texas, United States, 77058
        • Univ TX Med Branch
    • Washington
      • Tacoma, Washington, United States, 98405
        • Infections Ltd / Physicians Med Ctr
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Med Consultants LTD
      • Rhinelander, Wisconsin, United States, 54501
        • Rhinelander Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
  • Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
  • Life expectancy of at least 6 months.
  • Ability to cooperate with the requirements of the study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
  • Acute, life-threatening condition.
  • Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
  • Intolerance of oral medication.

Concurrent Medication:

Excluded:

  • Tricyclic antidepressants or anti-epileptics.
  • Topical applications to the zoster lesions that would obscure evaluation.
  • Fluorouracil and flucytosine.
  • Systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study).
  • Probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study).
  • Capsaicin (Zostrix).
  • Warfarin (Coumadin) during 14 days of treatment.

Patients with the following prior conditions are excluded:

History of intolerance, hypersensitivity, or severe drug reaction to acyclovir.

Prior Medication:

Excluded:

  • Systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks.
  • Probenecid or other drugs likely to affect the elimination of 882C87 or acyclovir within the past 48 hours.
  • Drugs likely to interact with 882C87 (e.g., fluorouracil or flucytosine) within the past 7 days.
  • Zoster immune globulin or zoster immune plasma within the previous month. History of alcohol or drug abuse within the previous 6 months or current methadone therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 1994

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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