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

This study has been completed.
Sponsor:
Collaborator:
Hoechst Marion Roussel
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002192
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  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 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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002192

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

No publications provided

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

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

Additional relevant MeSH terms:
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, Nontuberculous
Antitubercular Agents
Ethambutol
Rifapentine
Rifampin
Azithromycin
Clarithromycin
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 26, 2014