Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.

This study has been completed.
Hoechst Marion Roussel
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
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 2

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.

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


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:


  • 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:


  • 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.
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Please refer to this study by its identifier: NCT00002192

United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Anderson Clinical Research
Hoechst Marion Roussel
  More Information 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

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Antitubercular Agents

Additional relevant MeSH terms:
Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors processed this record on May 26, 2016