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Nevirapine and Fluconazole Interaction in HIV+ Patients
NCT02181946Phase 4
Key facts
- Status
- Completed
- Start
- May 2001
- Primary completion
- Jul 2001
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- nevirapine
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 4, open-label, single-arm trial of nevirapine in human immunodeficiency virus infection (HIV), sponsored by Boehringer Ingelheim. Primary endpoints: Maximum concentration of the analyte in plasma, Minimum concentration of the analyte in plasma and 1 more. Started May 2001; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Fluconazole with and without Nevirapine
Sequential administration of Fluconazole alone followed by Fluconazole + Nevirapine
03
Who it enrols
HIV+ patients aged 18-65 with CD4 >= 100, excluding those on interacting meds or with significant organ dysfunction.
04
Endpoints
Primary
Maximum concentration of the analyte in plasma
Minimum concentration of the analyte in plasma
Area under the plasma concentration time curve over the dosing interval
Secondary
Time of Cmax
Oral clearance (Cl/F)
Number of patients with adverse events
Number of patients with abnormal changes in laboratory parameters
Number of patients with clinically significant changes in vital signs
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