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

Sponsor

Pharmacia (Industry)

Overall Status

Completed

CT.gov ID

NCT00002343

Collaborator

(none)

200

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride Drug: Rifabutin	Phase 4

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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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).