NCT04553081CompletedPhase 4
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Virological and Immunological Assessment in HIV Positive Participants on 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 134 (actual)
- First submitted
- 29 May 2020
- Start date
- 26 May 2020
- Primary completion date
- 12 Mar 2026
- Lead sponsor
- University Hospital, Ghent
- Diseases
- HIV
- NCT number
- NCT04553081
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 134
- From 26 May 2020 to the primary completion date, 12 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previous virological failure \>200 copies/mL on NRTI
Other illness
- 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).
- Patients unable to understand the study protocol or any other condition that in the investigator's opinion may compromise compliance with the study protocol
- 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.
- 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
Lab values
- Creatinine Clearance \<50
- ALT \>5 times the ULN, OR ALT \>3xULN and bilirubin \>1.5xULN (with \>35% direct bilirubin)
Other
- Pregnancy or breastfeeding.
- Decompensated liver cirrhosis (Child-Pugh B/C)
- Documented M184V
Who the study is looking for
- Age = or \>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 INSTI based regimen.
- Females of childbearing potential should be on effective contraception
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.