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NCT00001030 · ClinicalTrials.gov registry record · Phase 3

The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

A Phase 3 study of HIV Infections and Mycobacterium Avium-Intracellulare Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
1,100
Enrollment target
20
Study locations

NCT00001030 is a Phase 3 study of HIV Infections and Mycobacterium Avium-Intracellulare Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,100 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (148% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT00001030, a Phase 3 study of HIV Infections and Mycobacterium Avium-Intracellulare Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
1,100 participants
Enrollment target
20
Study locations

Study Summary

To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.

Interventions

  • DRUG Rifabutin
  • DRUG Clarithromycin

Study Locations (20)

Illinois

  • Chicago Children's CRS - Chicago
  • Northwestern University CRS - Chicago
  • Cook County Hosp. CORE Ctr. - Chicago
  • Rush Univ. Med. Ctr. ACTG CRS - Chicago

Massachusetts

  • Massachusetts General Hospital ACTG CRS - Boston
  • Bmc Actg Crs - Boston
  • Beth Israel Deaconess - East Campus A0102 CRS - Boston
  • Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston

California

  • UCLA CARE Center CRS - Los Angeles
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. - Oakland
  • Ucsf Aids Crs - San Francisco

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
  • Methodist Hosp. of Indiana - Indianapolis

Alabama

  • Alabama Therapeutics CRS - Birmingham

District of Columbia

  • Howard University Hosp., Div. of Infectious Diseases, ACTU - Washington D.C.

Florida

  • Univ. of Miami AIDS CRS - Miami

Hawaii

  • Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu

Trial Details

FieldValue
Enrollment Target 1,100 participants
Est. Completion 1996-06
Phase Phase 3

What the Registry Record Tells You About NCT00001030

The ClinicalTrials.gov registry entry for NCT00001030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (148% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Rifabutin is the first listed.

NCT00001030 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Illinois, Massachusetts, California.

Frequently Asked Questions

What is clinical trial NCT00001030 about?

NCT00001030 is a clinical study titled "The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients". To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life a...

What is the current status of trial NCT00001030?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,100 participants. Estimated completion is 1996-06.

What conditions does trial NCT00001030 study?

This clinical trial studies the following conditions: HIV Infections, Mycobacterium Avium-Intracellulare Infection.

What interventions are being tested in trial NCT00001030?

The interventions under investigation include: Rifabutin (DRUG), Clarithromycin (DRUG).

Who is sponsoring clinical trial NCT00001030?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001030 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.