Optimization of Darunavir Therapy and Dosage Recommendations

NCT03101644 | Completed Phase 4 FDA Drug

• 1 other identifier: UCL-LB-02
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus I Infection

Outcome Measures

Primary Outcomes (5)

• Darunavir clearance

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

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

• Darunavir volume of distribution

  Assessment of darunavir volume of distribution through population pharmacokinetic methods

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

• Darunavir absorption rate

  Assessment of darunavir absorption rate through population pharmacokinetic methods

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

• Darunavir area under the concentration-time curve (AUC)

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

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

• Darunavir maximum plasma concentration (Cmax)

  Assessment of darunavir maximum plasma concentration through population pharmacokinetic methods

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

Secondary Outcomes (4)

• Frequency of adverse events/laboratory abnormalities

  Up to 18 months

• Change in viral load

  Up to 18 months

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

  Up to 18 months

• Ritonavir/cobicistat AUC

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

Study Arms (1)

Darunavir

OTHER

All patients treated with darunavir

Drug: Darunavir

Interventions

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)

Also known as: Prezista, Rezolsta

Darunavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving informed consent
• HIV-positive
• Routinely followed at the Cliniques universitaires Saint-Luc
• Treated with darunavir
• \- Perfect adherence to treatment (as assessed by anamnesis and based on available PK data for each patient)

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Stillemans G, Belkhir L, Vandercam B, Vincent A, Haufroid V, Elens L. Exploration of Reduced Doses and Short-Cycle Therapy for Darunavir/Cobicistat in Patients with HIV Using Population Pharmacokinetic Modeling and Simulations. Clin Pharmacokinet. 2021 Feb;60(2):177-189. doi: 10.1007/s40262-020-00920-z.

  PMID: 32696441 DERIVED

MeSH Terms

Interventions

Darunavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Leila Belkhir, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: March 23, 2017
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)