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Completed

NCT Number: NCT03101644

Optimization of Darunavir Therapy and Dosage Recommendations

This study will assess and characterize the variability observed in the response to darunavir therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV). More specifically, it aims to quantify variations in the drug's blood concentrations and determine the sources of such variability, both genetic and non-genetic. In light of this information, current dosage guidelines will then be reviewed.

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Key information

Conditions

Human Immunodeficiency Virus I Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darunavir

Drug

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: Prezista, Rezolsta

Primary outcomes

  1. Darunavir clearance

    Time frame: Up to 18 months (blood sampling for PK once at each visit, three visits per patient over the study period)

    Assessment of darunavir whole-body clearance and inter-compartmental clearance through population pharmacokinetic methods

  2. 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)

    Assessment of darunavir volume of distribution through population pharmacokinetic methods

  3. 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)

    Assessment of darunavir absorption rate through population pharmacokinetic methods

  4. 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)

    Assessment of darunavir area under the concentration-time curve through population pharmacokinetic methods

  5. 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)

    Assessment of darunavir maximum plasma concentration through population pharmacokinetic methods

Secondary outcomes

  1. Frequency of adverse events/laboratory abnormalities

    Time frame: Up to 18 months

    Assessment of the frequency of adverse events or laboratory abnormalities

  2. Change in viral load

    Time frame: Up to 18 months

    Assessment of the change in viral load (HIV copies/ml of blood)

  3. Change in blood Cluster of Differentiation 4 (CD4+) T lymphocyte count

    Time frame: Up to 18 months

    Assessment of the change in blood CD4+ T lymphocyte count

  4. 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)

    Assessment of the pharmacokinetic booster (either ritonavir or cobicistat, depending on the subject) AUC through population pharmacokinetic methods

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Registry information

Official study title

Optimization of Darunavir Therapy Through Population Pharmacokinetic Modeling, Simulations and Dosage Guidelines

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2017
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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