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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001023 |
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.
Condition | Intervention |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Clarithromycin Drug: Azithromycin Drug: Rifabutin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | Evaluation of the Safety, Tolerance and Pharmacokinetics of Rifabutin/Clarithromycin Combination and Rifabutin/Azithromycin Combination in HIV-Infected Patients |
Estimated Enrollment: | 91 |
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 drugs for 4 additional weeks. Patients are followed weekly. Pharmacokinetic sampling will be performed on days 14, 15, and 42-45.
ORIGINAL: Sixty-eight patients are randomly assigned to one of four groups (17 patients per group). They receive either clarithromycin or azithromycin in combination with rifabutin on one of two different dosing schedules. Patients receive medication for 6 weeks and undergo follow-up weekly during drug administration and at week 8.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
AMENDED (PART B):
ORIGINAL:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, Arizona | |
Univ of Arizona / Health Science Ctr | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
Palo Alto Veterans Affairs Health Care System | |
Palo Alto, California, United States, 94304 | |
United States, Colorado | |
Denver Public Health Dept | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Louisiana | |
Tulane Univ Med School | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Maryland | |
Univ of Maryland at Baltimore / Veterans Adm | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St Louis, Missouri, United States, 63108 | |
United States, North Carolina | |
Univ of North Carolina School of Medicine | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Rhode Island | |
Univ of Rhode Island / Roger Williams Med Ctr | |
Providence, Rhode Island, United States, 02908 | |
United States, Virginia | |
Med College of Virginia / School of Pharmacy | |
Richmond, Virginia, United States, 232980533 |
Study Chair: | R Hafner | |
Study Chair: | H Standiford |
Study ID Numbers: | DATRI 001 |
Study First Received: | November 2, 1999 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00001023 |
Health Authority: | United States: Federal Government |
Rifabutin Mycobacterium avium-intracellulare Infection Drug Interactions Azithromycin Clarithromycin |
Bacterial Infections Sexually Transmitted Diseases, Viral Rifabutin Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Mycobacterium Infections, Atypical Mycobacterium avium-intracellulare Infection Virus Diseases |
Clarithromycin Gram-Positive Bacterial Infections HIV Infections Azithromycin Sexually Transmitted Diseases Mycobacterium Infections Mycobacterium avium complex infection Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Protein Synthesis Inhibitors Therapeutic Uses Lentivirus Infections Antitubercular Agents |