A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Chickenpox
Intervention: Netivudine (Drug); Acyclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
Official title: A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
Study design: Treatment, Double-Blind, Safety Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SORRA / NC Research Ctr, Birmingham, Alabama 35234, United States
Simon - Williamson Clinic, Birmingham, Alabama 35211, United States
Univ of Arizona / Univ Med Ctr, Tucson, Arizona 85724, United States
AIDS Community Research Consortium, Redwood City, California 94063, United States
Cedars Sinai Med Ctr, Los Angeles, California 90048, 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 Health Sciences Univ, Portland, Oregon 97201, United States
Oregon Research Group, Eugene, Oregon 97401, 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
Rhinelander Med Ctr, Rhinelander, Wisconsin 54501, United States
Med Consultants LTD, Milwaukee, Wisconsin 53215, United States
Additional Information
Last updated: June 23, 2005
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