Search / Trial NCT00000641

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Rifampin Mycobacterium Avium Intracellulare Infection Drug Evaluation Drug Therapy, Combination Ethambutol Clofazimine Acquired Immunodeficiency Syndrome Amikacin Azithromycin Ciprofloxacin

Description

Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in t...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT) and didanosine (ddI). Dideoxycytidine (ddC), EPO, and other experimental therapies granted Treatment IND or Expanded Access status, with the exception of rifabutin.
  • Concurrent therapies (acute and maintenance) for opportunistic infections not specifically prohibited.
  • Concurrent Treatment:
  • Allowed:
  • Interferon-alfa.
  • Patients must have the following:
  • HIV infections or diagnosis of AIDS as per CDC classification.
  • Mycobacterium avium isolated from blood.
  • Capability of signing an informed consent, or consent of guardian if < 18 years of age.
  • Ability and willingness to participate in all components of the study and receive all study therapies.
  • Prior Medication:
  • Allowed:
  • Interferon-alfa.
  • Single drug prophylaxis for Mycobacterium avium or M. tuberculosis within the previous 4 weeks.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Treatment Phase:
  • Known or suspected allergy to any of the study medications. Severe hearing loss.
  • Maintenance Phase:
  • Severe hearing loss. Hypersensitivity to macrolides. Intolerance to ethambutol and clofazimine.
  • Concurrent Medication:
  • Excluded:
  • Acute therapy for other opportunistic infections at time of study entry.
  • Nephrotoxic agents such as amphotericin B, intravenous vancomycin, or foscarnet during the first 4 weeks of study therapy without specific exemption from one of the protocol chairs. Antacids within 2 hours of ingestion of study drugs.
  • Immunomodulators (except interferon-alfa) and other antimycobacterial drugs (including quinolones and aminoglycosides).
  • All experimental therapies (except ddI, ddC, and other experimental agents granted "Treatment IND" or "expanded access" status) will be prohibited (specific exemptions must be obtained from one of the protocol chairs).
  • Patients with the following are excluded:
  • Known or suspected allergy to any of the study medications. Cannot take drugs orally.
  • Severe hearing loss, at the discretion of the investigator.
  • Prior Medication:
  • Excluded:
  • Antimycobacterial drugs (including azithromycin, clarithromycin, rifamycins, quinolones, and aminoglycosides) or immunomodulators (except interferon-alfa) within 4 weeks prior to entry, except single-drug prophylaxis specifically allowed.
  • History of unreliable drug intake.
  • Inability to cooperate in the testing procedures.

Attachments

readout_NCT00000641_2024-03-05.pdf

4.5 MB

NCT00000641_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Torrance, California, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Newark, New Jersey, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Seattle, Washington, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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2 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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