search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Erythromycin
Nevirapine
Clarithromycin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antibiotics, Macrolide, Clarithromycin, Nevirapine, Reverse Transcriptase Inhibitors, Cytochrome P-450, Anti-HIV Agents

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Florida Bioavailability Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00002194
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antibiotics, Macrolide, Clarithromycin, Nevirapine, Reverse Transcriptase Inhibitors, Cytochrome P-450, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Clarithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
South Florida Bioavailability Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
331813405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs