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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002194 |
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 |
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HIV Infections |
Drug: Erythromycin Drug: Nevirapine Drug: Clarithromycin |
Phase I |
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. |
Estimated Enrollment: | 36 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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:
Prior Medication:
Excluded:
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 ID Numbers: | 200G |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002194 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antibiotics, Macrolide Clarithromycin Nevirapine |
Reverse Transcriptase Inhibitors Cytochrome P-450 Anti-HIV Agents |
Erythromycin stearate Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Erythromycin Ethylsuccinate Acquired Immunodeficiency Syndrome Erythromycin Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Bacterial Agents Clarithromycin Nevirapine Anti-Retroviral Agents Erythromycin Estolate HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Clarithromycin Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Gastrointestinal Agents Enzyme Inhibitors Erythromycin Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Protein Synthesis Inhibitors Nevirapine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |