Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil

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.

Conditions

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

Interventions

OTHER

No intervention

This will be an observational study, no intervention will be performed

Sponsors & Collaborators

• University of New Mexico

  collaborator OTHER

• Instituto Infectologia Evandro Chagas, Rio de Janeiro

  collaborator UNKNOWN

• Fundação de Medicina Tropical de Manaus

  collaborator UNKNOWN

• Hospital de Clinicas de Porto Alegre

  collaborator OTHER

• Centro de Referência e Tratamento, CRT, São Paulo, SP

  collaborator UNKNOWN

• Hospital Partenon, Porto Alegre

  collaborator UNKNOWN

• Universidade Municipal de São Caetano do Sul

  collaborator UNKNOWN

• Universidade Federal do Rio Grande do Norte

  collaborator OTHER

• Hospital Universitário Cassiano Antônio de Moraes/HUCAM

  collaborator UNKNOWN

• Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto/USP

  collaborator UNKNOWN

• Faculdade de Medicina de Botucatu, Unesp

  collaborator UNKNOWN

• Sociedade Campineira de Educação e Instrução - Campinas

  collaborator UNKNOWN

• Fundação Universidade de Caxias do Sul - FUCS/RS

  collaborator UNKNOWN

• Fundação Bahiana de Infectologia

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2024-12-31

Completion

2025-02-28

Countries

• Brazil

Study Locations