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

HIV Infections Clinical Trial

Official title:

A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002315
• Other study ID #: 130A
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1994
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• HIV Infections

Intervention

Drug:
• Netivudine

• Acyclovir

Locations

Country	Name	City	State
United States	New Mexico Med Group	Albuquerque	New Mexico
United States	Simon - Williamson Clinic	Birmingham	Alabama
United States	SORRA / NC Research Ctr	Birmingham	Alabama
United States	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas
United States	Med Associates Clinic	Dubuque	Iowa
United States	Oregon Research Group	Eugene	Oregon
United States	Jordon Diagnostics and Research Inc	High Point	North Carolina
United States	MacGregor Med Association	Houston	Texas
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Med Consultants LTD	Milwaukee	Wisconsin
United States	Vanderbilt Med Ctr	Nashville	Tennessee
United States	Univ TX Med Branch	Nassau Bay	Texas
United States	Oschner Clinic	New Orleans	Louisiana
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	AIDS Community Research Consortium	Redwood City	California
United States	Rhinelander Med Ctr	Rhinelander	Wisconsin
United States	Saint Francis Mem Hosp	San Francisco	California
United States	Washington Univ	St. Louis	Missouri
United States	Sunnyvale Med Clinic	Sunnyvale	California
United States	Infections Ltd / Physicians Med Ctr	Tacoma	Washington
United States	Clinical Research Consultants	Trumbull	Connecticut
United States	Univ of Arizona / Univ Med Ctr	Tucson	Arizona
United States	Hanover Med Specialists	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,