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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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002315 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Chickenpox
  • Drug: Netivudine
  • Drug: Acyclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002315
130A
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP