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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 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.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Est. Completion | 1998-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001023
The ClinicalTrials.gov registry entry for NCT00001023 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). 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 3 interventions - of which Azithromycin is the first listed.
NCT00001023 reports 11 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Related
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