Clinical Research Directory

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)

Sponsor: ANRS, Emerging Infectious Diseases

Summary

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.

Key Details

Conditions

Locations (3)