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NCT00001023 · ClinicalTrials.gov registry record · NA

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

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

Completed
Registry status
NA
Development phase
91
Enrollment target
11
Study locations

NCT00001023: Completed NA study of HIV Infections and Mycobacterium Avium-Intracellulare Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00001023 is a NA 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 91 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001023, a NA study of HIV Infections and Mycobacterium Avium-Intracellulare Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
91 participants
Enrollment target
11
Study locations

Study Summary

PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin (three potential agents against Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts \< 200 cells/mm3. ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI serum levels. 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.

Conditions Studied

HIV Infections Mycobacterium Avium-Intracellulare Infection

Interventions

  • DRUG Azithromycin
  • DRUG Rifabutin
  • DRUG Clarithromycin

Study Locations (11)

California

  • Palo Alto Veterans Affairs Health Care System - Palo Alto
  • Davies Med Ctr - San Francisco

Arizona

  • Univ of Arizona / Health Science Ctr - Tucson

Colorado

  • Denver Public Health Dept - Denver

District of Columbia

  • Georgetown Univ Med Ctr - Washington D.C.

Louisiana

  • Tulane Univ Med School - New Orleans

Maryland

  • Univ of Maryland at Baltimore / Veterans Adm - Baltimore

Missouri

  • Washington Univ School of Medicine - St Louis

North Carolina

  • Univ of North Carolina School of Medicine - Chapel Hill

Trial Details

FieldValue
Enrollment Target 91 participants
Est. Completion 1998-07
Phase NA
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00001023 record still lists

NCT00001023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower).

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Azithromycin is the first listed.

NCT00001023 lists 11 locations in 10 states (California, Arizona, Colorado).

Frequently Asked Questions

What is clinical trial NCT00001023 about?

NCT00001023 is a clinical study titled "The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients". PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To gain preliminary information about the safet...

What is the current status of trial NCT00001023?

This trial is currently completed. It is a NA study. The enrollment target is 91 participants. Estimated completion is 1998-07.

What conditions does trial NCT00001023 study?

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

What interventions are being tested in trial NCT00001023?

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

Who is sponsoring clinical trial NCT00001023?

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 NCT00001023 being conducted?

This trial has 11 study locations across Arizona, California, Colorado, District of Columbia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00001023's enrollment target sits among peer trials

91 286th of 542 higher than 257 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00001023, the US trial registry maintained by the National Library of Medicine. NCT00001023 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.