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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002343
• Other study ID #: 048E
• Secondary ID: CS 087287-000
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-Intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Ethambutol hydrochloride

• Rifabutin

Locations

Country	Name	City	State
United States	Univ of California - Davis Med Ctr / CARES	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia

Country where clinical trial is conducted

United States,