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OpenTrials
Completed

NCT Number: NCT00001995

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rifabutin

Drug

Sponsors and collaborators

Lead sponsor

Pharmacia

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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