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A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

Primary Purpose

Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Rifabutin
Fluconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycoses focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Mycoses, Drug Therapy, Combination, Fluconazole, Acquired Immunodeficiency Syndrome, Azithromycin

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Preventive therapy with isoniazid for M. tuberculosis. Maintenance therapy for CMV retinitis. Patients must have: HIV infection or history of an AIDS-defining condition by CDC criteria. One documented CD4 count < 100 cells/mm3 within 12 months prior to study entry. NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous). NO acute opportunistic infection. Life expectancy of more than 6 months. Consent of parent or guardian if less than legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: ALL PATIENTS - Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded. Serious hypersensitivity reactions to macrolides or rifampin. Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION - Serious hypersensitivity reaction to fluconazole. Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis). Positive baseline urine cryptococcal culture. Concurrent Medication: Excluded for fluconazole randomization: Maintenance therapy for deep fungal infections. Chronic therapy with ketoconazole or fluconazole.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • UCI Med Ctr
  • UCSD Treatment Ctr / Dept of Medicine and Pediatrics
  • Santa Clara Valley Med Ctr
  • Harbor - UCLA Med Ctr
  • Georgetown Univ Med Ctr
  • George Washington Univ Med Ctr
  • Univ of Massachusetts Med Ctr
  • Univ of Pennsylvania
  • Univ of Texas Southwestern Med Ctr
  • Baylor College of Medicine
  • Houston Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00002122
Brief Title
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Official Title
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
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
Pfizer

4. Oversight

5. Study Description

Brief Summary
PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population. SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.
Detailed Description
Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections
Keywords
Rifabutin, Mycobacterium avium-intracellulare Infection, Mycoses, Drug Therapy, Combination, Fluconazole, Acquired Immunodeficiency Syndrome, Azithromycin

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Preventive therapy with isoniazid for M. tuberculosis. Maintenance therapy for CMV retinitis. Patients must have: HIV infection or history of an AIDS-defining condition by CDC criteria. One documented CD4 count < 100 cells/mm3 within 12 months prior to study entry. NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous). NO acute opportunistic infection. Life expectancy of more than 6 months. Consent of parent or guardian if less than legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: ALL PATIENTS - Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded. Serious hypersensitivity reactions to macrolides or rifampin. Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION - Serious hypersensitivity reaction to fluconazole. Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis). Positive baseline urine cryptococcal culture. Concurrent Medication: Excluded for fluconazole randomization: Maintenance therapy for deep fungal infections. Chronic therapy with ketoconazole or fluconazole.
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Havlir DV, Mccutchan JA, Bozzette SA, Dunne M. A double-blind, randomized study of weekly azithromycin, daily rifabutin, and combination azithromycin and rifabutin for the prevention of Mycobactetum avium complex (MAC) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90
Results Reference
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A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

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