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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002122
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Mycoses Mycobacterium Avium-Intracellulare Infection HIV Infections Drug: Azithromycin Drug: Rifabutin Drug: Fluconazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 720 participants
Masking: Double
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002122

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United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCI Med Ctr
Orange, California, United States, 92668
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, United States, 92103
Santa Clara Valley Med Ctr
San Jose, California, United States, 951282699
Harbor - UCLA Med Ctr
Torrance, California, United States, 90509
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Massachusetts
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Pennsylvania
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77005
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Sponsors and Collaborators

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

Layout table for additonal information Identifier: NCT00002122     History of Changes
Other Study ID Numbers: 226A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996
Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
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Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents