Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 dis...
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 dise...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1996
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00001030
End Date
June 1 1996
Last Update
November 1 2021
Active Locations (42)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
3
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
4
Ucsf Aids Crs
San Francisco, California, United States