An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

• ClinicalTrials.gov Identifier: NCT00002194
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Boehringer Ingelheim
• Information provided by: NIH AIDS Clinical Trials Information Service

Tracking Information

• First Submitted Date: November 2, 1999
• First Posted Date: August 31, 2001
• Last Update Posted Date: June 24, 2005
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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.
• 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.
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: HIV Infections

Intervention

• Drug: Erythromycin
• Drug: Nevirapine
• Drug: Clarithromycin

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 36
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00002194
• Other Study ID Numbers: 200G
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: NIH AIDS Clinical Trials Information Service
• Verification Date: August 2002