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Sponsors and Collaborators: |
Anderson Clinical Research Hoechst Marion Roussel |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002192 |
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 |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Rifapentine Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Azithromycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
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.
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:
Study ID Numbers: | 275A, 000473PR0018, 96ACR-HMD1 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002192 History of Changes |
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 |
Bacterial Infections Anti-Infective Agents Opportunistic Infections Sexually Transmitted Diseases, Viral Clarithromycin Anti-Bacterial Agents Gram-Positive Bacterial Infections Azithromycin AIDS-Related Opportunistic Infections Retroviridae Infections Systemic Inflammatory Response Syndrome Acquired Immunodeficiency Syndrome Rifapentine |
Bacteremia Immunologic Deficiency Syndromes Mycobacterium Infections, Atypical Mycobacterium Avium Complex Infection Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Sepsis HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Antitubercular Agents |
Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Clarithromycin Gram-Positive Bacterial Infections Pathologic Processes Therapeutic Uses Azithromycin Retroviridae Infections Systemic Inflammatory Response Syndrome |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Rifapentine Bacteremia Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Antibiotics, Antitubercular Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Protein Synthesis Inhibitors |