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CompletedNCT00002343Updated Jun 24, 2005

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

A Phase 4 interventional study of Ethambutol hydrochloride and Rifabutin in Mycobacterium Avium-Intracellulare Infection and HIV Infections, sponsored by Pharmacia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Pharmacia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections

Keywords

  • Rifabutin
  • Mycobacterium avium-intracellulare Infection
  • Drug Therapy, Combination
  • Ethambutol
  • Acquired Immunodeficiency Syndrome
03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 4,199 interventional studies indexed under Infections.

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Lead sponsor

Pharmacia is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
200 participants

Interventions

  • DrugEthambutol hydrochloride
  • DrugRifabutin
06

Study locations

1 site
  • Univ of California - Davis Med Ctr / CARES
    Sacramento, California 95817, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002343
Lead sponsor
Pharmacia
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 1997. You cannot join it, but the record below documents what was studied.

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