The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination.

AMENDED 03/10/94 (Part B): Approximately 38 HIV-infected or uninfected subjects are randomized to receive azithromycin or rifabutin (Groups 3 and 4) daily for 14 days, followed by a combination regimen of both...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine.
• • Any approved therapy for antiretroviral treatment, or antiretroviral therapy available through FDA-sanctioned treatment IND or treatment protocol.
• Patients must have:
• AMENDED (PART B):
• • Either HIV infection OR no HIV infection.
• • CD4 count unspecified.
• ORIGINAL:
• • Documented HIV infection.
• • CD4 count \< 200 cells/mm3 within 90 days prior to study entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Known Mycobacterium avium-intracellulare (MAI) bacteremia or presence of a clinical syndrome compatible with MAI (i.e., fevers, weight loss, elevated LDH and alkaline phosphatase).
• • Fever = or \> 38.5 deg C (100.4 deg F) within 7 days prior to study entry.
• Concurrent Medication:
• Excluded:
• • Acute or chronic use of phenobarbital, carbamazepine, rifampin, dilantin, fluconazole, itraconazole, ketoconazole, ciprofloxacin, beta-blockers, or clarithromycin.
• • Oral contraceptives.
• • Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection.
• • Maintenance therapy for CMV, cryptococcal meningitis, or toxoplasmosis.
• • Cytotoxic chemotherapy.
• Patients with the following prior conditions are excluded:
• • History of intolerance or hypersensitivity to study drugs, other macrolide antibiotics, or rifampin.
• • Three or more loose bowel movements per day within 3 months prior to study entry.
• • Unintentional weight loss \>= 5 percent of body weight within 3 months prior to study entry.
• Prior Medication:
• Excluded:
• • Rifabutin within 30 days prior to study entry.
• • Clarithromycin or azithromycin within 14 days prior to study entry.
• • Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection within 28 days prior to study entry.
• Prior Treatment:
• Excluded:
• • Blood transfusions within 1 month prior to study entry.

Trial Officials