![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Anderson Clinical Research Hoechst Marion Roussel |
---|---|
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 |
---|---|---|
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 |
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 |
Systemic Inflammatory Response Syndrome Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Rifapentine Bacteremia Mycobacterium Infections, Atypical Immunologic Deficiency Syndromes Inflammation Mycobacterium avium-intracellulare Infection Virus Diseases |
Clarithromycin Gram-Positive Bacterial Infections Sepsis HIV Infections Azithromycin AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Mycobacterium avium complex infection Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection Actinomycetales Infections |
Pharmacologic Actions Antibiotics, Antitubercular Protein Synthesis Inhibitors Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Lentivirus Infections Antitubercular Agents Leprostatic Agents |