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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002343

Enrollment

200

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Keywords

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

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.

Interventions

DRUGEthambutol hydrochloride

DRUGRifabutin

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026