HIV infection
Conditions
Interventions
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DOLUTEGRAVIR
CAS Number: 1051375-16-6
Current Sponsor code: DTG
Other descriptive name: DOLUTEGRAVIR
Concentration unit: mg milligram(s)
Concent
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and currently treated by DTG (n=80) or BIC (n=30). - Virally controlled immunologically functional HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and shifting from another ARV class to DTG (n=20) or BIC (n=20). - HIV infected adult patient retrospectively identified as having stopped DTG due to NPAE (insomnia, depression, anxiety) (n=50). Identification will be based on the interrogation of our prospective clinical database. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Pregnancy at the time of inclusion or expected pregnancy within 12 months, for patients treated by DTG or BIC during the study - Liver failure (Child-Pugh A, B or C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -The impact of genetic polymorphisms in biotransformation enzymes and transport proteins on DTG/BIC plasma trough (C0) and intracellular (IC) concentrations -The impact of C0 and IC concentrations on residual viremia (i.e. HIV viremia below 40 copies/ml). -The impact of genetic polymorphisms in biotransformation enzymes and transport proteins on residual viremia. -The impact of C0 and IC concentrations on the occurrence of neuropsychiatric adverse and on weight gain under DTG or BIC. -The impact of genetic polymorphisms in biotransformation enzymes and transport proteins on weight gain and neuropsychiatric adverse events under DTG and BIC. -How INSTIs affect the gut microbiome of treated patients, and to determine in turn how and by which pathways the gut microbiome might influence the clinical response (i.e. efficacy and toxicity) to INSTIs. ;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactGuichet Académique
Clinical Trial Center
Outcome results
None listed