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.
The study is conducted in two separate groups. Patients in Group I receive clarithromycin
orally for 32 days and nevirapine orally for 28 days.
Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and
nevirapine orally for 28 days.
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.
Patients may be on clarithromycin at study entry.
Patients with the following conditions are excluded:
Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.
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
- 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
Radiotherapy within 12 weeks of study entry.
Current history (within the last year) of IVDA, ETOH, or substance abuse.