The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients
NCT ID: NCT00001023
Last Updated: 2012-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
1998-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Clarithromycin
Azithromycin
Rifabutin
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine.
* Any approved therapy for antiretroviral treatment, or antiretroviral therapy available through FDA-sanctioned treatment IND or treatment protocol.
Patients must have:
AMENDED (PART B):
* Either HIV infection OR no HIV infection.
* CD4 count unspecified.
ORIGINAL:
* Documented HIV infection.
* CD4 count \< 200 cells/mm3 within 90 days prior to study entry.
Exclusion Criteria
Patients with the following symptoms and conditions are excluded:
* Known Mycobacterium avium-intracellulare (MAI) bacteremia or presence of a clinical syndrome compatible with MAI (i.e., fevers, weight loss, elevated LDH and alkaline phosphatase).
* Fever = or \> 38.5 deg C (100.4 deg F) within 7 days prior to study entry.
Concurrent Medication:
Excluded:
* Acute or chronic use of phenobarbital, carbamazepine, rifampin, dilantin, fluconazole, itraconazole, ketoconazole, ciprofloxacin, beta-blockers, or clarithromycin.
* Oral contraceptives.
* Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection.
* Maintenance therapy for CMV, cryptococcal meningitis, or toxoplasmosis.
* Cytotoxic chemotherapy.
Patients with the following prior conditions are excluded:
* History of intolerance or hypersensitivity to study drugs, other macrolide antibiotics, or rifampin.
* Three or more loose bowel movements per day within 3 months prior to study entry.
* Unintentional weight loss \>= 5 percent of body weight within 3 months prior to study entry.
Prior Medication:
Excluded:
* Rifabutin within 30 days prior to study entry.
* Clarithromycin or azithromycin within 14 days prior to study entry.
* Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection within 28 days prior to study entry.
Prior Treatment:
Excluded:
* Blood transfusions within 1 month prior to study entry.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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R Hafner
Role: STUDY_CHAIR
H Standiford
Role: STUDY_CHAIR
Locations
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Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, United States
Davies Med Ctr
San Francisco, California, United States
Denver Public Health Dept
Denver, Colorado, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Univ of Rhode Island / Roger Williams Med Ctr
Providence, Rhode Island, United States
Med College of Virginia / School of Pharmacy
Richmond, Virginia, United States
Countries
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References
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Hafner R, Bethel J, Standiford HC, Follansbee S, Cohn DL, Polk RE, Mole L, Raasch R, Kumar P, Mushatt D, Drusano G; DATRI 001B Study Group. Tolerance and pharmacokinetic interactions of rifabutin and azithromycin. Antimicrob Agents Chemother. 2001 May;45(5):1572-7. doi: 10.1128/AAC.45.5.1572-1577.2001.
Other Identifiers
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11732
Identifier Type: REGISTRY
Identifier Source: secondary_id
DATRI 001
Identifier Type: -
Identifier Source: org_study_id