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A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

Primary Purpose

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Rifabutin
Sponsored by
Pharmacia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Required: AZT, d4T, ddI, or ddC. Antipneumocystis prophylaxis. Allowed: Short course (< 14 days) of ciprofloxacin for acute infections. Patients must have: AIDS. CD4 count <= 100 cells/mm3. NO prior or current MAC infection. Prior Medication: Required: Antipneumocystis prophylaxis for at least 4 weeks prior to study entry. Allowed: Prior rifabutin. Prior ethambutol. Prior clarithromycin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Positive tuberculin skin test (PPD > 5 mm). Active M. tuberculosis. Perceived as unreliable or unavailable for frequent monitoring. Concurrent Medication: Excluded: Other antiretrovirals not specifically allowed. All investigational drugs. Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days). Patients with the following prior conditions are excluded: Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol. Prior Medication: Excluded within 4 weeks prior to study entry: Rifampin. Isoniazid. Clofazimine. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin.

Sites / Locations

  • Univ of California - Davis Med Ctr / CARES

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia
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1. Study Identification

Unique Protocol Identification Number
NCT00002343
Brief Title
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
Official Title
An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
June 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
Pharmacia

4. Oversight

5. Study Description

Brief Summary
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Detailed Description
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.

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
Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Rifabutin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: AZT, d4T, ddI, or ddC. Antipneumocystis prophylaxis. Allowed: Short course (< 14 days) of ciprofloxacin for acute infections. Patients must have: AIDS. CD4 count <= 100 cells/mm3. NO prior or current MAC infection. Prior Medication: Required: Antipneumocystis prophylaxis for at least 4 weeks prior to study entry. Allowed: Prior rifabutin. Prior ethambutol. Prior clarithromycin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Positive tuberculin skin test (PPD > 5 mm). Active M. tuberculosis. Perceived as unreliable or unavailable for frequent monitoring. Concurrent Medication: Excluded: Other antiretrovirals not specifically allowed. All investigational drugs. Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days). Patients with the following prior conditions are excluded: Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol. Prior Medication: Excluded within 4 weeks prior to study entry: Rifampin. Isoniazid. Clofazimine. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin.
Facility Information:
Facility Name
Univ of California - Davis Med Ctr / CARES
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

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