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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Erythromycin; Drug: Nevirapine; Drug: Clarithromycin

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
• Enrollment: 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 331813405
      • South Florida Bioavailability Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: August 1, 2002

More Information

Terms related to this study

• Keywords: Nevirapine; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Clarithromycin; Antibiotics, Macrolide; Cytochrome P-450
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Nevirapine; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Clarithromycin
• Other Study ID Numbers: 200G