Comparing dual therapy to triple therapy for HIV-1 treatment
Virological and Immunological Assessment in HIV Positive Participants on 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
This study is testing if switching from a traditional three-drug HIV treatment to a two-drug treatment can keep patients healthy without causing problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04553081 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of switching from a traditional triple drug regimen (3DR) to a dual therapy regimen (2DR) in patients with HIV-1 infection. Participants will be monitored for virological and immunological markers to assess the safety and efficacy of the 2DR regimen, specifically looking at viral load, immune system function, and potential health complications. The study seeks to determine if the dual therapy can maintain virological control without increasing the HIV reservoir or causing immune exhaustion. This research is particularly relevant given the recent paradigm shift towards dual therapy in HIV treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have maintained an HIV RNA level of less than 50 copies/mL on a second-generation integrase inhibitor regimen for at least three months.
Not a fit: Patients currently experiencing opportunistic infections or active hepatitis infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more cost-effective long-term treatment option for patients with HIV-1.
How similar studies have performed: Previous studies, such as the TANGO and GEMINI studies, have shown promising results for dual therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Linos Vandekerckhove — University Hospital, Ghent
- Study coordinator: Marie-Angelique De Scheerder
- Email: marieangelique.descheerder@ugent.com
- Phone: 003293321349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.