Search / Trial NCT00001023

The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

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

Rifabutin Mycobacterium Avium Intracellulare Infection Drug Interactions Azithromycin Clarithromycin

Description

Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination. AMENDED 03/10/94 (Part B): Approximately 38 HIV-infected or uninfected subjects are randomized to receive azithromycin or rifabutin (Groups 3 and 4) daily for 14 days, followed by a combination regimen of both...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine.
  • Any approved therapy for antiretroviral treatment, or antiretroviral therapy available through FDA-sanctioned treatment IND or treatment protocol.
  • Patients must have:
  • AMENDED (PART B):
  • Either HIV infection OR no HIV infection.
  • CD4 count unspecified.
  • ORIGINAL:
  • Documented HIV infection.
  • CD4 count < 200 cells/mm3 within 90 days prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Known Mycobacterium avium-intracellulare (MAI) bacteremia or presence of a clinical syndrome compatible with MAI (i.e., fevers, weight loss, elevated LDH and alkaline phosphatase).
  • Fever = or > 38.5 deg C (100.4 deg F) within 7 days prior to study entry.
  • Concurrent Medication:
  • Excluded:
  • Acute or chronic use of phenobarbital, carbamazepine, rifampin, dilantin, fluconazole, itraconazole, ketoconazole, ciprofloxacin, beta-blockers, or clarithromycin.
  • Oral contraceptives.
  • Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection.
  • Maintenance therapy for CMV, cryptococcal meningitis, or toxoplasmosis.
  • Cytotoxic chemotherapy.
  • Patients with the following prior conditions are excluded:
  • History of intolerance or hypersensitivity to study drugs, other macrolide antibiotics, or rifampin.
  • Three or more loose bowel movements per day within 3 months prior to study entry.
  • Unintentional weight loss >= 5 percent of body weight within 3 months prior to study entry.
  • Prior Medication:
  • Excluded:
  • Rifabutin within 30 days prior to study entry.
  • Clarithromycin or azithromycin within 14 days prior to study entry.
  • Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection within 28 days prior to study entry.
  • Prior Treatment:
  • Excluded:
  • Blood transfusions within 1 month prior to study entry.

Attachments

readout_NCT00001023_2024-03-05.pdf

4.5 MB

NCT00001023_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

New Orleans, Louisiana, United States

Washington, District Of Columbia, United States

St Louis, Missouri, United States

San Francisco, California, United States

Denver, Colorado, United States

Baltimore, Maryland, United States

Palo Alto, California, United States

Tucson, Arizona, United States

Chapel Hill, North Carolina, United States

Providence, Rhode Island, United States

Richmond, Virginia, 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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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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