NCT04326504

Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Fundação Bahiana de Infectologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infections
• Clinical Outcomes
• Adverse Drug Event
• Effect of Drugs

Interventions

Type	Name	Description
OTHER	No intervention	This will be an observational study, no intervention will be performed

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2020-03-30
• Last updated: 2024-02-26

Locations

3 sites across 1 country: Brazil