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Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
EU CTIS ID: 2024-515265-34-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
- Creatinine Clearance <50.
- Tuberculosis treatment.
- Documented M184V.
- Previous virological failure >200 copies/mL on NRTI.
See the full eligibility 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 < 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
- 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.
- Creatinine Clearance <50.
- Tuberculosis treatment.
- Documented M184V.
- Previous virological failure >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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.