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
NCT number | NCT00002315 |
Other study ID # | 130A |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | |
Est. primary completion date | |
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. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Glaxo Wellcome |
United States,
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