Actively Recruiting
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Led by University Hospital, Ghent · Updated on 2024-02-28
134
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
V
ViiV Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability and willingness to provide written informed consent
- Ability to attend all scheduled assessments and visits
- Willingness to have blood samples collected and stored indefinitely for research
- HIV RNA less than 50 copies/mL for at least 3 months on a 2nd generation integrase inhibitor based regimen
- Females of childbearing potential must use effective contraception
You will not qualify if you...
- Current opportunistic infection as defined by CDC category C AIDS events
- Active hepatitis B infection without seroconversion
- Active hepatitis C infection with recent positive viral load
- Pregnancy or breastfeeding
- Inability to understand the study protocol or conditions compromising study compliance
- Decompensated liver cirrhosis (Child-Pugh B or C)
- Unstable liver disease or known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- Psychiatric or psychological disorders interfering with study conduct or safety
- Previous participation in trials with immune modulating agents
- Active drug or alcohol addiction interfering with adherence
- Treatment failure on integrase inhibitor regimen with baseline resistance
- Creatinine clearance below 50
- Current tuberculosis treatment
- Documented M184V mutation
- Previous virological failure above 200 copies/mL on NRTI
- History or presence of allergy to study drugs or components
- ALT greater than 5 times the upper limit of normal or ALT greater than 3 times with bilirubin over 1.5 times the upper limit
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
M
Marie-Angelique De Scheerder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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