A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
1 other identifier
interventional
400
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (25)
Simon - Williamson Clinic
Birmingham, Alabama, 35211, United States
SORRA / NC Research Ctr
Birmingham, Alabama, 35234, United States
Univ of Arizona / Univ Med Ctr
Tucson, Arizona, 85724, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
Sunnyvale Med Clinic
Sunnyvale, California, 94086, United States
Clinical Research Consultants
Trumbull, Connecticut, 06611, United States
Med Associates Clinic
Dubuque, Iowa, 52001, United States
Oschner Clinic
New Orleans, Louisiana, 70121, United States
Washington Univ
St Louis, Missouri, 63110, United States
New Mexico Med Group
Albuquerque, New Mexico, 87110, United States
Jordon Diagnostics and Research Inc
High Point, North Carolina, 27262, United States
Hanover Med Specialists
Wilmington, North Carolina, 28401, United States
Oregon Research Group
Eugene, Oregon, 97401, United States
Oregon Health Sciences Univ
Portland, Oregon, 97201, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Silver Lake Med Inc
Providence, Rhode Island, 02909, United States
Vanderbilt Med Ctr
Nashville, Tennessee, 37232, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
MacGregor Med Association
Houston, Texas, 77054, United States
Univ TX Med Branch
Nassau Bay, Texas, 77058, United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405, United States
Med Consultants LTD
Milwaukee, Wisconsin, 53215, United States
Rhinelander Med Ctr
Rhinelander, Wisconsin, 54501, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1994-05