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| Sponsor: | Anderson Clinical Research |
|---|---|
| Collaborator: |
Hoechst Marion Roussel |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002192 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Rifapentine Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Azithromycin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002192 History of Changes |
| Other Study ID Numbers: | 275A, 000473PR0018, 96ACR-HMD1 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Antitubercular Agents |
Azithromycin Clarithromycin Bacteremia rifapentine |
|
HIV Infections Acquired Immunodeficiency Syndrome Bacteremia Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Bacterial Infections |
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Actinomycetales Infections Gram-Positive Bacterial Infections Mycobacterium Infections, Atypical Antitubercular Agents Ethambutol Rifapentine Rifampin Azithromycin Clarithromycin Anti-Bacterial Agents |