The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients
Evaluation of the Safety, Tolerance and Pharmacokinetics of Rifabutin/Clarithromycin Combination and Rifabutin/Azithromycin Combination in HIV-Infected Patients
2 other identifiers
interventional
91
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 31, 2012
October 1, 2012
November 2, 1999
October 29, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Denver Public Health Dept
Denver, Colorado, 802044507, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, 21201, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215, United States
Univ of Rhode Island / Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Med College of Virginia / School of Pharmacy
Richmond, Virginia, 232980533, United States
Related Publications (1)
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.
PMID: 11302832BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R Hafner
- STUDY CHAIR
H Standiford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
July 1, 1998
Last Updated
October 31, 2012
Record last verified: 2012-10