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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)

NCT05312918 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 603

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • CIRBA, Abidjan, Ivory Coast

    collaborator UNKNOWN

  • SEREFO, Bamako, Mali

    collaborator UNKNOWN

  • BIOLIM/FSS/UL, Lomé, Togo

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Avelin AGHOKENG · IRD 224 - CNRS 5290 - UM1-UM2

  • Anoumou Claver DAGNRA · BIOLIM - FSS - UL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-03-31
Completion
2024-10-31

Countries

  • Côte d’Ivoire
  • Mali
  • Togo

Study Locations

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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 NCT05312918 on ClinicalTrials.gov