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

Primary Purpose

HIV Infections, Chickenpox

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Netivudine
Acyclovir
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Simon - Williamson Clinic
  • SORRA / NC Research Ctr
  • Univ of Arizona / Univ Med Ctr
  • Cedars Sinai Med Ctr
  • AIDS Community Research Consortium
  • Saint Francis Mem Hosp
  • Sunnyvale Med Clinic
  • Clinical Research Consultants
  • Med Associates Clinic
  • Oschner Clinic
  • Washington Univ
  • New Mexico Med Group
  • Jordon Diagnostics and Research Inc
  • Hanover Med Specialists
  • Oregon Research Group
  • Oregon Health Sciences Univ
  • Roger Williams Med Ctr
  • Silver Lake Med Inc
  • Vanderbilt Med Ctr
  • N Texas Ctr for AIDS & Clin Rsch
  • MacGregor Med Association
  • Univ TX Med Branch
  • Infections Ltd / Physicians Med Ctr
  • Med Consultants LTD
  • Rhinelander Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002315
Brief Title
A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
Official Title
A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Chickenpox
Keywords
Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Netivudine
Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Simon - Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
SORRA / NC Research Ctr
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Univ of Arizona / Univ Med Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Sunnyvale Med Clinic
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Clinical Research Consultants
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Med Associates Clinic
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Oschner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New Mexico Med Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
Jordon Diagnostics and Research Inc
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Hanover Med Specialists
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Oregon Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Silver Lake Med Inc
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02909
Country
United States
Facility Name
Vanderbilt Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
N Texas Ctr for AIDS & Clin Rsch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
MacGregor Med Association
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Univ TX Med Branch
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Infections Ltd / Physicians Med Ctr
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Med Consultants LTD
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Rhinelander Med Ctr
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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