Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
Key facts
- Where
- Gent, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- Universitair Ziekenhuis GentGent, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Ziekenhuis Gent
- Trial code
- EU 2024-515265-34-00
- Record updated
- 2024. október 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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 < 50 copies/mL for at least 3 months on a 2nd generation integrase inhibitor (INSTI) based regimen; Females of childbearing potential should be on effective contraception.
Exclusion: Previous virological failure >200 copies/mL on NRTI; 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; 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; Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification); Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance; Tuberculosis treatment; Subjects with history or presence of allergy to any of the study drugs or their components; 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); 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; Creatinine Clearance <50; ALT >5 times the ULN, OR ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin); Documented M184V; Pregnancy or breastfeeding.