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

NCT00002194 | Completed Phase 1

• 1 other identifier: 200G
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Antibiotics, Macrolide; Clarithromycin; Nevirapine; Reverse Transcriptase Inhibitors; Cytochrome P-450; Anti-HIV Agents

Interventions

Erythromycin DRUG

Nevirapine DRUG

Clarithromycin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

South Florida Bioavailability Clinic

Miami, Florida, 331813405, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Erythromycin; Nevirapine; Clarithromycin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-08

Locations

US (1)