A Phase 2 interventional study of Rifapentine and Ethambutol hydrochloride in Mycobacterium Avium-Intracellulare Infection and HIV Infections, sponsored by Anderson Clinical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Anderson Clinical Research · Phase 2, Interventional, and Treatment
To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.
In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.
In the combination treatment phase, 12 patients each are randomized to one of three arms:
Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.
Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
Browse Infections studies →Anderson Clinical Research is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must have:
Prior Medication:
Allowed:
MAC prophylaxis with medications other than study drugs (5-day washout period required).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
This study is completed, as verified in Aug 1997. You cannot join it, but the record below documents what was studied.
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Anderson Clinical Research