- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101644
Optimization of Darunavir Therapy and Dosage Recommendations
Optimization of Darunavir Therapy Through Population Pharmacokinetic Modeling, Simulations and Dosage Guidelines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data will be used to create a population pharmacokinetic model. Inter- and intra-individual pharmacokinetic variability will be quantified and linked to patient-specific covariates, both genetic and non-genetic in nature. Pharmacokinetic-pharmacodynamic relationships will be established, linking drug exposure to efficacy (as measured by CD4 cell count and viral load reduction) and toxicity (as measured by frequency and degree of adverse events). Simulations will be conducted for specific patient profiles and current dosage guidelines reviewed.
Pharmacokinetic design : combined sparse/intensive sampling
- Sparse sampling : One blood sample collected in each individual at a random post-intake time (during a routine visit to the hospital), up to three times over the course of the study period (months 1-18).
- Intensive sampling : Eight blood samples collected over six hours in a subset of twelve individuals (during an additional observation period, months 19-22).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capable of giving informed consent
- HIV-positive
- Routinely followed at the Cliniques universitaires Saint-Luc
- Treated with darunavir
Inclusion Criteria (intensive sampling):
- Perfect adherence to treatment (as assessed by anamnesis and based on available PK data for each patient)
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Darunavir
All patients treated with darunavir
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The investigated drugs are Prezista (darunavir 600 mg twice-daily or 800 mg once-daily) and Rezolsta (darunavir 800 mg/cobicistat 150 mg once-daily)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Darunavir clearance
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of darunavir whole-body clearance and inter-compartmental clearance through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Darunavir volume of distribution
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of darunavir volume of distribution through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Darunavir absorption rate
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of darunavir absorption rate through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Darunavir area under the concentration-time curve (AUC)
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of darunavir area under the concentration-time curve through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Darunavir maximum plasma concentration (Cmax)
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of darunavir maximum plasma concentration through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events/laboratory abnormalities
Time Frame: Up to 18 months
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Assessment of the frequency of adverse events or laboratory abnormalities
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Up to 18 months
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Change in viral load
Time Frame: Up to 18 months
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Assessment of the change in viral load (HIV copies/ml of blood)
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Up to 18 months
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Change in blood Cluster of Differentiation 4 (CD4+) T lymphocyte count
Time Frame: Up to 18 months
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Assessment of the change in blood CD4+ T lymphocyte count
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Up to 18 months
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Ritonavir/cobicistat AUC
Time Frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Assessment of the pharmacokinetic booster (either ritonavir or cobicistat, depending on the subject) AUC through population pharmacokinetic methods
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Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leila Belkhir, MD, Cliniques Universitaires Saint-Luc
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Darunavir
Other Study ID Numbers
- UCL-LB-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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