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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Chickenpox

Intervention: Netivudine (Drug); Acyclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Glaxo Wellcome

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.

Clinical Details

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Simon - Williamson Clinic, Birmingham, Alabama 35211, United States

SORRA / NC Research Ctr, Birmingham, Alabama 35234, United States

Univ of Arizona / Univ Med Ctr, Tucson, Arizona 85724, United States

Cedars Sinai Med Ctr, Los Angeles, California 90048, United States

AIDS Community Research Consortium, Redwood City, California 94063, United States

Saint Francis Mem Hosp, San Francisco, California 94109, United States

Sunnyvale Med Clinic, Sunnyvale, California 94086, United States

Clinical Research Consultants, Trumbull, Connecticut 06611, United States

Med Associates Clinic, Dubuque, Iowa 52001, United States

Oschner Clinic, New Orleans, Louisiana 70121, United States

Washington Univ, St. Louis, Missouri 63110, United States

New Mexico Med Group, Albuquerque, New Mexico 87110, United States

Jordon Diagnostics and Research Inc, High Point, North Carolina 27262, United States

Hanover Med Specialists, Wilmington, North Carolina 28401, United States

Oregon Research Group, Eugene, Oregon 97401, United States

Oregon Health Sciences Univ, Portland, Oregon 97201, United States

Roger Williams Med Ctr, Providence, Rhode Island 02908, United States

Silver Lake Med Inc, Providence, Rhode Island 02909, United States

Vanderbilt Med Ctr, Nashville, Tennessee 37232, United States

N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas 75219, United States

MacGregor Med Association, Houston, Texas 77054, United States

Univ TX Med Branch, Nassau Bay, Texas 77058, United States

Infections Ltd / Physicians Med Ctr, Tacoma, Washington 98405, United States

Med Consultants LTD, Milwaukee, Wisconsin 53215, United States

Rhinelander Med Ctr, Rhinelander, Wisconsin 54501, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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