Search / 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

Launched by PFIZER · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Rifabutin Mycobacterium Avium Intracellulare Infection Mycoses Drug Therapy, Combination Fluconazole Acquired Immunodeficiency Syndrome Azithromycin

ClinConnect Summary

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.

Gender

ALL

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.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

Houston, Texas, United States

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

Houston, Texas, United States

Worcester, Massachusetts, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Torrance, California, United States

Dallas, Texas, United States

Orange, California, United States

San Diego, California, United States

San Jose, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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