Clinical trial NCT00002315: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Chickenpox
Keywords: Herpes Zoster
Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon - Williamson Clinic
state: Alabama
city: Birmingham
country: United States
facility: SORRA / NC Research Ctr
state: Alabama
city: Tucson
country: United States
facility: Univ of Arizona / Univ Med Ctr
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Med Ctr
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
city: Sunnyvale
country: United States
facility: Sunnyvale Med Clinic
state: California
city: Trumbull
country: United States
facility: Clinical Research Consultants
state: Connecticut
city: Dubuque
country: United States
facility: Med Associates Clinic
state: Iowa
city: New Orleans
country: United States
facility: Oschner Clinic
state: Louisiana
city: St. Louis
country: United States
facility: Washington Univ
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico Med Group
state: New Mexico
city: High Point
country: United States
facility: Jordon Diagnostics and Research Inc
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Med Specialists
state: North Carolina
city: Eugene
country: United States
facility: Oregon Research Group
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Providence
country: United States
facility: Silver Lake Med Inc
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Med Ctr
state: Tennessee
city: Dallas
country: United States
facility: N Texas Ctr for AIDS & Clin Rsch
state: Texas
city: Houston
country: United States
facility: MacGregor Med Association
state: Texas
city: Nassau Bay
country: United States
facility: Univ TX Med Branch
state: Texas
city: Tacoma
country: United States
facility: Infections Ltd / Physicians Med Ctr
state: Washington
city: Milwaukee
country: United States
facility: Med Consultants LTD
state: Wisconsin
city: Rhinelander
country: United States
facility: Rhinelander Med Ctr
state: Wisconsin
Study officials:
References: