An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 2002
History of Changes
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.
Drug : Erythromycin
Drug : Nevirapine
Drug : Clarithromycin
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- History of drug allergy or known drug hypersensitivity.
- History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.
- 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
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:
Radiotherapy within 12 weeks of study entry.
Current history (within the last year) of IVDA, ETOH, or substance abuse.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002194
Locations Show More
|United States, Florida|
|South Florida Bioavailability Clinic|
|Miami, Florida, United States, 331813405|
Sponsors and CollaboratorsBoehringer Ingelheim
|Responsible Party:||Boehringer Ingelheim|
|ClinicalTrials.gov Identifier:||NCT00002194 History of Changes|
|Other Study ID Numbers:||200G|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Antibiotics, Macrolide
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.