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

Completed · Phase 3

Conditions studied: HIV Infections, Chickenpox

In brief

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.

Key facts

Study ID

NCT00002315

Run by

Glaxo Wellcome

People needed

400

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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