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A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001995
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

HIV Infections, Mycobacterium Avium-Intracellulare Infection

Keywords

Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome

Brief summary

To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Interventions

DRUGRifabutin

Sponsors

Pharmacia
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Concurrent Medication: Allowed: * Zidovudine (AZT). * Didanosine (ddI). Patients must have the following: * Diagnosis of AIDS as defined by the CDC. * Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB). * Provide written informed consent. Prior Medication: Allowed: * If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry. * Required: * Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion criteria

Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Known hypersensitivity to any of the study drugs. Concurrent Medication: Excluded: * Other therapy for mycobacterial disease. Patients with the following are excluded: * Known hypersensitivity to any of the study drugs. Prior Medication: Excluded within 4 weeks: * Therapy for mycobacterial disease. * Antiretroviral drugs, other than zidovudine (AZT) or ddI. * Investigational drugs, other than ddI.

Countries

United States

Outcome results

None listed

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