human immunodeficiency viruses (HIV)
Conditions
Interventions
Trade Name: Dovato
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DOLUTEGRAVIR
Other descriptive name: DOLUTEGRAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Ability and willingness to provide written informed consent - Ability to attend the complete schedule of assessments and patient visits - Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes - HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: - Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification) - Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (seroconversion= HBV antigen or viral load negative and positive HBV surface antibody) - Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry - Pregnancy or breastfeeding - Patients unable to understand the study protocol or any other condition that in the investigator’s opinion may compromise compliance with the study protocol - Decompensated liver cirrhosis (Child-Pugh B/C). Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones) - Psychiatric and psychological disorders, which in the opinion of the investigator, will interfere with the trial conduct or safety of the participant - Previous participation in a trial evaluating an immune modulating agent - Active drug or alcohol use/addiction such that, in the opinion of the site investigator, would interfere with adherence to study requirements - Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance - Creatinine Clearance 200 copies/mL on NRTI - Subjects with history or presence of allergy to any of the study drugs or their components - ALT =5 times the ULN, OR ALT =3xULN and bilirubin =1.5xULN (with >35% direct bilirubin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in HIV-1 infected individuals in terms of the amount of intact replication-competent HIV-1 sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.;Secondary Objective: 1) Quantification of immune activation markers in both arms, will be explored and should not differ more than 20%. 2) To assess impact of the DTG/3TC vs BIC/FTC/TAF on metabolic health; evolutions of these outcomes will be compared among the DTG/3TC vs BIC/FTC/TAF group. 3) To assess the impact of switching through a patient questionnaire. 4) To demonstrate non inferiority at W144 and W240 of the 2DR DTG/3TC vs BIC/TAF/FTC in terms of the amount of intact replication-competent HIV-1 sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells. 5) In all participants or in a subgroup indientified as high and very high C-V risk group will be proposed a duplex carotis at W240 to assess the intima media tickness as a surrogate marker for generalised atherosclerosis and risk of cardio-vascular disease. ;Primary end point(s): The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.;Timepoint(s) of evaluation of this end point: W240 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points: - Quantification of viral markers as total HIV DNA, and RNA transcripts - Full length sequencing of the virus - Quantification of human pro-inflammatory mediators and markers of microbial translocation - Phenotype of innate immune cells - Function of immune cells - Metabolic parameters - Analysis of cardio-vascular risk in all or a subgroup of individuals. Tertiary end point: Patient satisfaction.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of secondary end points: W240 Timepoint of evaluation of tertiary end point: W24 | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed