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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002315
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1994
  Purpose

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.


Condition Intervention Phase
HIV Infections
Chickenpox
Drug: Netivudine
Drug: Acyclovir
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 400
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002315

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002315     History of Changes
Other Study ID Numbers: 130A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Zoster
Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chickenpox
Herpes Zoster
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014