The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

Phase 3

Completed

• Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

• Registration Number: NCT00001030
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions.

Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.

Detailed Description

Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.

Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study. Patients are followed for 24 months. Per amendment, a pharmacokinetic substudy will be conducted.

Study Timeline

• Study Completion: 1996-06
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (42)

Alabama Therapeutics CRS; 🇺🇸 Birmingham, Alabama, United States

UCLA CARE Center CRS; 🇺🇸 Los Angeles, California, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.; 🇺🇸 Oakland, California, United States

Ucsf Aids Crs; 🇺🇸 San Francisco, California, United States

Howard University Hosp., Div. of Infectious Diseases, ACTU; 🇺🇸 Washington, District of Columbia, United States

Univ. of Miami AIDS CRS; 🇺🇸 Miami, Florida, United States

Univ. of Hawaii at Manoa, Leahi Hosp.; 🇺🇸 Honolulu, Hawaii, United States

Chicago Children's CRS; 🇺🇸 Chicago, Illinois, United States

Northwestern University CRS; 🇺🇸 Chicago, Illinois, United States

Cook County Hosp. CORE Ctr.; 🇺🇸 Chicago, Illinois, United States

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