The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients
Status:
Completed
Trial end date:
1998-07-01
Target enrollment:
Participant gender:
Summary
PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels
of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve
(AUC) when these drugs are taken concomitantly.
ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of
clarithromycin and azithromycin in combination with rifabutin (three potential agents against
Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3.
ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the
macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the
effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP
prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI
serum levels.
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.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)