- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002122
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: 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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Orange, California, United States, 92668
- UCI Med Ctr
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San Diego, California, United States, 92103
- UCSD Treatment Ctr / Dept of Medicine and Pediatrics
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San Jose, California, United States, 951282699
- Santa Clara Valley Med Ctr
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Torrance, California, United States, 90509
- Harbor - UCLA Med Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
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Washington, District of Columbia, United States, 20007
- Georgetown Univ Med Ctr
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- Univ of Massachusetts Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania
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Texas
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Dallas, Texas, United States, 75235
- Univ of Texas Southwestern Med Ctr
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Houston, Texas, United States, 77030
- Houston Veterans Administration Med Ctr
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Houston, Texas, United States, 77005
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Mycoses
- Mycobacterium avium-intracellulare Infection
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Antitubercular Agents
- 14-alpha Demethylase Inhibitors
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Rifabutin
- Azithromycin
- Fluconazole
Other Study ID Numbers
- 226A
- 066-174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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