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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Erythromycin Drug: Nevirapine Drug: Clarithromycin	Phase I

MedlinePlus related topics:

AIDS

Drug Information available for:

Clarithromycin Nevirapine Erythromycin Erythromycin estolate Erythromycin ethylsuccinate Erythromycin Gluceptate Erythromycin stearate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study

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:

Estimated Enrollment:

36

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002194

Locations


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

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	200G
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002194
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Antibiotics, Macrolide

Clarithromycin

Nevirapine

Reverse Transcriptase Inhibitors

Cytochrome P-450

Anti-HIV Agents

Study placed in the following topic categories:

Erythromycin stearate

Sexually Transmitted Diseases, Viral

Erythromycin Ethylsuccinate

Acquired Immunodeficiency Syndrome

Erythromycin

Immunologic Deficiency Syndromes

Virus Diseases

Clarithromycin

Nevirapine

Erythromycin Estolate

HIV Infections

Sexually Transmitted Diseases

Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Gastrointestinal Agents

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Protein Synthesis Inhibitors

Anti-Bacterial Agents

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002194