Status:
RECRUITING
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 th...
Detailed Description
In HIV care we have been facing a paradigm change over the last years, reaching an ultimatum with the reimbursement of a 2DR regimen both in naïve as in switch patients. The rationale behind dual the...
Eligibility Criteria
Inclusion Criteria:
- 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
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 <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)
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04553081
Start Date
May 26 2020
End Date
April 30 2027
Last Update
February 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ghent University Hospital
Ghent, Belgium, 9000