2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial

Launched by UNIVERSITY HOSPITAL, GHENT · Sep 16, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether switching from a traditional three-drug HIV treatment (3DR) to a two-drug therapy (2DR) is safe and effective for people living with HIV. The study will track important health markers, including the level of HIV in the blood and the health of the immune system, to see if this change in medication affects patients’ overall health. Researchers want to ensure that the two-drug regimen doesn't increase the amount of HIV in the body or cause other health problems over time.

To join this study, participants must be at least 18 years old, have maintained a low level of HIV in their blood for at least three months, and be willing to attend regular check-ups and provide blood samples. Participants can expect to be monitored closely for their health throughout the trial. It's important to note that individuals with certain health conditions, like active infections or severe liver disease, cannot participate, as the study aims to ensure the safety of all involved.

Gender

ALL

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)