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

Primary Purpose

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rifapentine
Ethambutol hydrochloride
Clarithromycin
Azithromycin
Sponsored by
Anderson Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Antitubercular Agents, Azithromycin, Clarithromycin, Bacteremia, rifapentine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hampton Roads Med Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Anderson Clinical Research
Collaborators
Hoechst Marion Roussel
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1. Study Identification

Unique Protocol Identification Number
NCT00002192
Brief Title
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
Official Title
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anderson Clinical Research
Collaborators
Hoechst Marion Roussel

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Antitubercular Agents, Azithromycin, Clarithromycin, Bacteremia, rifapentine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifapentine
Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Type
Drug
Intervention Name(s)
Azithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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