Search / Trial NCT00001058

A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS

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

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Rifabutin Mycobacterium Avium Intracellulare Infection Drug Therapy, Combination Ethambutol Clofazimine Acquired Immunodeficiency Syndrome Ciprofloxacin Clarithromycin

Description

It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones. Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone i...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Maintenance or prophylactic therapy for other opportunistic infections (with the exception of specifically excluded drugs).
  • Carbamazepine or theophylline.
  • Isoniazid for TB prophylaxis.
  • PER AMENDMENT 10/10/96:
  • Therapy for acute infectious processes, other than MAC, provided that the patient is stable on the therapy.
  • Fluconazole therapy for maintenance or suppression of fungal infections, providing the patient has been on a stable dose for at least 4 weeks.
  • PER AMENDMENT 7/02/97:
  • If a patient elects to receive indinavir, ORTHO/NOVUM 1/35 is an acceptable means of birth control.
  • Patients must have:
  • HIV infection.
  • Disseminated MAC disease.
  • Life expectancy of at least 8 weeks.
  • Consent of parent or guardian if under 18 years of age.
  • NOTE:
  • This protocol is approved for prisoner participation.
  • Prior Medication:
  • Allowed:
  • PER AMENDMENT 10/10/96:
  • Therapy for acute infectious processes, other than MAC, prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active mycobacterial infection other than MAC that requires treatment, with the exception of isoniazid used solely for TB prophylaxis.
  • Concurrent Medication:
  • Excluded:
  • Other antimycobacterial drugs (with the exception of isoniazid for TB prophylaxis).
  • Other investigational drugs unless approved by protocol chair.
  • PER AMENDMENT 7/2/97:
  • For patients who elect to receive indinavir or ritonavir:
  • Terfenadine, astemizole, cisapride, triazolam, or midazolam.
  • For patients who elect to receive ritonavir:
  • alprazolam, amiodarone, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, ergotamine, estazolam, encainide, flecainide, flurazepam, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine or zolpidem.
  • For patients who elect to receive indinavir:
  • oral contraceptives other than ORTHO/NOVUM as a sole form of birth control.
  • For patients randomized to a rifabutin-containing arm:
  • oral contraceptives or Norplant as a sole form of birth control.
  • Patients with the following prior condition are excluded:
  • History of severe hypersensitivity to erythromycin, clarithromycin, azithromycin, ethambutol, rifampin, or rifabutin (including Type 1 hypersensitivity reaction, Stevens-Johnson syndrome, hepatitis, optic neuritis, or exfoliative dermatitis).
  • Prior Medication:
  • Excluded:
  • Empiric or presumptive antimycobacterial therapy prior to study entry if > 14 days, within 90 days prior to entry.
  • NOTE:
  • Patients unwilling to discontinue presumptive therapy or empiric therapy may be enrolled with the permission of the protocol chairs, however, if they are without a MAC positive blood culture at baseline, they will have study medications discontinued (AS PER AMENDMENT 7/2/97).
  • PER AMENDMENT 10/10/96:
  • Treatment with clarithromycin or ethambutol within 4 days of initiation of study medications.
  • Treatment with rifabutin or rifampin within 7 days of initiation of study medications.

Attachments

readout_NCT00001058_2024-04-22.pdf

4.5 MB

NCT00001058_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

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Diego, California, United States

San Francisco, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, 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

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Mbeya, , Tanzania

Chicago, Illinois, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Indianapolis, Indiana, 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
41
4 stars
6
3 stars
2
2 stars
0
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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