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

NCT04553081 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-02-28

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Dual versus triple therapy in treatment of HIV-1 infection.

cfr arm description

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Linos Vandekerckhove · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2026-06-30
Completion
2027-04-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553081 on ClinicalTrials.gov