HIV Infections Clinical Trial
Official title:
Evaluation of the Safety, Tolerance and Pharmacokinetics of Rifabutin/Clarithromycin Combination and Rifabutin/Azithromycin Combination in HIV-Infected Patients
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.
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 drugs for 4 additional weeks. Patients are followed weekly.
Pharmacokinetic sampling will be performed on days 14, 15, and 42-45.
ORIGINAL: Sixty-eight patients are randomly assigned to one of four groups (17 patients per
group). They receive either clarithromycin or azithromycin in combination with rifabutin on
one of two different dosing schedules. Patients receive medication for 6 weeks and undergo
follow-up weekly during drug administration and at week 8.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment
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