Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)

Brief summary (registry, in English)

Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy. Secondary objectives * Determine the level of virological suppression (HIV-1 RNA \<200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line. * Determine the level of virological suppression at the WHO threshold (HIV-1 RNA \<1000 copies/ml). * To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO. * To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors. * Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches. Identify program factors associated with virological failure and/or the development of drug resistance.

What you commit to

• Study type: Observational
• Participants enrolled: 487
• From 9 Sept 2022 to the primary completion date, 9 Sept 2023
• 3 sites in 3 countries
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (3)

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