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

Study acronym: 2DR
StatusCompleted
PhasePhase 4
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2026 to Mar 12, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 22 entries
    • Study description expanded, about 10 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Aug 8, 2022 to Jun 30, 2026
    • Study description expanded, about 1,155 words
    v6
  3. Trial status: Active, Not Recruiting to Recruiting
    • Study completion date: Apr 30, 2025 to Apr 30, 2027
    • Secondary endpoints: 20 to 22
    • Site details revised
    v5
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of May 31, 2023 to Aug 8, 2022
    • Site details revised
    v4
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v3
  6. Primary endpoint revisedv2 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 134
    • Study completion date: May 31, 2023 to Apr 30, 2025
    • Secondary endpoints expanded, about 105 words
    • Site details revised
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04553081
Lead Sponsor University Hospital, Ghent
Collaborators: ViiV Healthcare
Conditions
(from sponsor)		 HIV-1-infection
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov