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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002194
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


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
Choosing 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
United States, Florida
South Florida Bioavailability Clinic
Miami, Florida, United States, 331813405
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002194     History of Changes
Other Study ID Numbers: 200G
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Clarithromycin
Erythromycin
Nevirapine
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014