An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
NCT ID: NCT00002194
Last Updated: 2005-06-24
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
PHASE1
36 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.
Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Erythromycin
Nevirapine
Clarithromycin
Eligibility Criteria
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Inclusion Criteria
Allowed:
Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication \> 25% within 4 weeks of study entry.
Patients must have:
* HIV positive status.
* CD4 count \>= 100 cells/mm3.
Prior Medication:
Allowed:
Patients may be on clarithromycin at study entry.
Exclusion Criteria
Patients with the following conditions are excluded:
Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.
Concurrent Medication:
Excluded:
Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.
Patients with the following prior conditions are excluded:
* History of drug allergy or known drug hypersensitivity.
* History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.
Prior Medication:
Excluded:
* Investigational drugs or antineoplastic agents within 12 weeks of study entry.
* Participation in a clinical trial that used ERMBY within one year of study entry.
* Systemic treatment with drugs known to be potent hepatic enzyme inducers or inhibitors (e.g., oral macrolide antibiotics, azole antifungals, cimetidine, rifampin, rifabutin, and carbamazepine) within 28 days of study entry.
* Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.
Prior Treatment:
Excluded:
Radiotherapy within 12 weeks of study entry.
Risk Behavior:
Excluded:
Current history (within the last year) of IVDA, ETOH, or substance abuse.
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Locations
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South Florida Bioavailability Clinic
Miami, Florida, United States
Countries
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Other Identifiers
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200G
Identifier Type: -
Identifier Source: org_study_id