- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002192
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
-
Hampton, Virginia, United States, 23666
- Hampton Roads Med Specialists
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- Documented positive HIV serology status.
- Documented AIDS.
- Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE:
- Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation.
- Minimum of two MAC-associated symptoms, defined as >= grade 1 fever; > grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss > 5% reported within 4 weeks prior to study entry.
- Life expectancy of at least 3 months.
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:
- Pulmonary tuberculosis.
- Infections requiring the use of disallowed medications.
- Serious diseases that introduce undue risks for adverse reactions to study medication.
Concurrent Medication:
Excluded:
- Terfenadine.
- Treatment for pulmonary TB.
- Study drugs from an outside source.
- Medications with anti-MAC activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin).
Patients with the following prior conditions are excluded:
- History of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol.
- Previous episode of uveitis.
Prior Medication:
Excluded:
- Prophylactic treatment for MAC with rifabutin or any of the study medications.
- Azithromycin within the 3 weeks prior to randomization.
- Any investigational drug during the 4 weeks prior to randomization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Sepsis
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Bacteremia
- Mycobacterium avium-intracellulare Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Rifapentine
- Clarithromycin
- Azithromycin
- Ethambutol
Other Study ID Numbers
- 275A
- 000473PR0018
- 96ACR-HMD1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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