An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
Key facts
- Study ID
- NCT00002194
- Run by
- Boehringer Ingelheim
- People needed
- 36
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- 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.
You may not qualify if…
- Co-existing Condition:
- 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.
Where it is running
- South Florida Bioavailability Clinic — Miami, Florida, United States
Full record on ClinicalTrials.gov
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