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

Completed · Phase 3

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001030

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1100

Expected to finish

1996-06-01

Last updated by the study team

2021-11-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Recommended:
• PCP prophylaxis.
• Allowed:
• GM-CSF or G-CSF.
• Erythropoietin.
• Therapies (including antiretrovirals) available through expanded access or treatment IND programs.
• Other non-experimental therapies available by prescription.
• Antihistamines other than those specifically excluded.
• Patients must have:
• Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by CDC criteria.
• CD4 count <= 100 cells/mm3 within 90 days prior to study entry.
• Two baseline blood sample cultures negative for MAC within 30 days of study entry.
• No suspected disseminated MAC disease, in the opinion of the clinician.
• NOTE:
• Patients with elevated GGT and/or triglycerides are allowed.
• NOTE:
• Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241, or other acceptable protocols.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Known or suspected tuberculous infection or other non-tuberculous mycobacterial infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid prophylaxis alone).
• NOTE:
• Patients may enroll who successfully completed tuberculosis (TB) treatment and have been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial infection.
• Active TB.
• Known hypersensitivity to study drugs.
• Malabsorption as defined by persistent diarrhea with more than 8 stools per day for > 6 weeks.
• Concurrent Medication:
• Excluded:
• Frequent (more than once per month), repeated, or continuous treatment courses of quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin.
• Concomitant terfenadine or astemizole.
• Prior Medication:
• Excluded:
• Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.

Where it is running

• 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 D.C., 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
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. — Omaha, Nebraska, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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