Integrative Assessment of Total and Intact HIV-1 Reservoir by a 5-Region Multiplexed Rainbow DNA Digital PCR Assay.
Mareva Delporte, Laurens Lambrechts, Evy E Blomme...
https://pubmed.ncbi.nlm.nih.gov/39749517Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04553081
Virological and Immunological Assessment in HIV Positive Participants on Dual Therapy Versus Triple Therapy in a Randomized Switch Trial
Led by University Hospital, Ghent · Updated on 2024-02-28
134
Participants Needed
1
Research Sites
43 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
Researchers are studying HIV-1 infected adults who are currently on a stable triple drug regimen to see how switching to a dual therapy affects the virus and immune system. This trial compares dual therapy with dolutegravir and lamivudine (DTG/3TC, Dovato) against a triple regimen with bictegravir, tenofovir alafenamide, and emtricitabine (BIC/TAF/FTC, Biktarvy). The main goal is to check if the dual therapy is not worse than the triple therapy in terms of the amount of intact HIV virus in blood cells after 48 weeks, while monitoring immune activation and inflammation markers. Participants will be randomly assigned to either continue their triple therapy or to switch to dual therapy. The study includes a 48-week primary period and extends up to 240 weeks to assess longer-term effects. Researchers will measure viral sequences, immune system markers, metabolic health indicators like weight and insulin resistance, and body composition using scans such as DXA and FibroScan. Patient experiences will also be evaluated through questionnaires. During the study, participants will attend regular visits for blood sample collection and assessments of viral load, immune function, metabolic health, and liver condition. These include measuring markers like interleukin-6, C-reactive protein, T cell activation and exhaustion indicators, and others. The study aims to ensure safety and monitor any health complications over nearly five years. Participants must agree to ongoing blood sample storage for research and complete scheduled assessments throughout the study.
CONDITIONS
Brief Title
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Who Can Participate
Age: 18Years +
All Genders
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 second generation integrase inhibitor based regimen
- Females of childbearing potential must use effective contraception
You will not qualify if you...
- Current opportunistic infection or AIDS defining event
- Active hepatitis B infection without evidence of seroconversion
- Active hepatitis C infection within 60 days prior to study entry
- Pregnancy or breastfeeding
- Inability to understand the study protocol or conditions compromising compliance
- Decompensated or unstable liver disease, cirrhosis, or known biliary abnormalities (except certain benign conditions)
- Psychiatric or psychological disorders interfering with safety or trial conduct
- Previous participation in trials with immune modulating agents
- Active drug or alcohol addiction interfering with study adherence
- Treatment failure on integrase inhibitor regimen with reported baseline resistance
- Creatinine clearance below 50
- Tuberculosis treatment
- Documented M184V mutation
- Previous virological failure over 200 copies/mL on NRTI
- Allergy to any study drugs or components
- Elevated liver enzymes beyond specified limits (ALT and bilirubin) indicating liver damage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 weeks
Participants receive either dual therapy (DTG/3TC) or triple therapy (BIC/TAF/FTC) for HIV-1 infection and are monitored for virological and immunological responses as well as metabolic health.
Multiple visits over 48 weeks including baseline, Week 48, and Week 144 assessments
Follow-up
Duration - Up to 192 weeks after treatment period, total study duration up to 240 weeks
Participants are followed up to assess long-term virological, immunological, and metabolic outcomes, including extended assessments up to Week 240.
Follow-up visits continuing through Week 240
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
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Research Team
M
Marie-Angelique De Scheerder
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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Published Research Related To This Trial
In-depth Analysis of the HIV Reservoir Confirms Effectiveness and Safety of Dolutegravir/Lamivudine in a Phase 4 Randomized Controlled Switch Trial (RUMBA).
Marie-Angélique De Scheerder, Sophie Degroote, Mareva Delporte...
https://pubmed.ncbi.nlm.nih.gov/39226296