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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.

Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002315
  Purpose

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.


Condition Intervention Phase
HIV Infections
Chickenpox
Drug: Netivudine
Drug: Acyclovir
Phase III

MedlinePlus related topics:   AIDS    Chickenpox    Shingles   

ChemIDplus related topics:   Acyclovir    Acyclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
Official Title:   A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   400

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002315

Show 25 study locations  Show 25 Study Locations

Sponsors and Collaborators
Glaxo Wellcome
  More Information


Study ID Numbers:   130A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002315
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Zoster  
Acyclovir  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Antiviral Agents  

Study placed in the following topic categories:
Herpes Zoster
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Chickenpox
AIDS-Related Complex
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Chicken pox
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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