Search / Trial NCT00002194

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

Launched by BOEHRINGER INGELHEIM · Aug 30, 2001

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Trial Information

Current as of December 07, 2024

Completed

Keywords

Antibiotics, Macrolide Clarithromycin Nevirapine Reverse Transcriptase Inhibitors Cytochrome P 450 Anti Hiv Agents

ClinConnect Summary

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.

Gender

ALL

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.

About Boehringer Ingelheim

Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.

Locations

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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