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Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil — CODE  

HIV Infections Clinical Trial

Official title:
Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study

Clinical Trial Summary

Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and lamivudine, for first-line ART; however, there is still a need for further data on the outcomes of DTG-based regimens for people with HIV-1. This study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (DTG)-based regimen in a large cohort of HIV - infected patients in Brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-DTG-based ART.

Clinical Trial Description

CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1). Enrolled patients will be followed for 36 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04326504
Study type Observational [Patient Registry]
Source Fundação Bahiana de Infectologia
Contact Carlos Brites, MD, PhD
Phone 557132838123
Email crbrites@gmail.com
Status Recruiting
Phase
Start date February 1, 2021
Completion date February 28, 2025
View Details
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