A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
NCT ID: NCT00002315
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Netivudine
Acyclovir
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Simon - Williamson Clinic
Birmingham, Alabama, United States
SORRA / NC Research Ctr
Birmingham, Alabama, United States
Univ of Arizona / Univ Med Ctr
Tucson, Arizona, United States
Cedars Sinai Med Ctr
Los Angeles, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
Sunnyvale Med Clinic
Sunnyvale, California, United States
Clinical Research Consultants
Trumbull, Connecticut, United States
Med Associates Clinic
Dubuque, Iowa, United States
Oschner Clinic
New Orleans, Louisiana, United States
Washington Univ
St Louis, Missouri, United States
New Mexico Med Group
Albuquerque, New Mexico, United States
Jordon Diagnostics and Research Inc
High Point, North Carolina, United States
Hanover Med Specialists
Wilmington, North Carolina, United States
Oregon Research Group
Eugene, Oregon, United States
Oregon Health Sciences Univ
Portland, Oregon, United States
Roger Williams Med Ctr
Providence, Rhode Island, United States
Silver Lake Med Inc
Providence, Rhode Island, United States
Vanderbilt Med Ctr
Nashville, Tennessee, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States
MacGregor Med Association
Houston, Texas, United States
Univ TX Med Branch
Nassau Bay, Texas, United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, United States
Med Consultants LTD
Milwaukee, Wisconsin, United States
Rhinelander Med Ctr
Rhinelander, Wisconsin, United States
Countries
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Other Identifiers
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130A
Identifier Type: -
Identifier Source: org_study_id