Evidence map›Paper›PMID 41062955›Full record

Observational studyBMC infectious diseases2025

Clinical outcomes of dolutegravir treatment in people living with HIV in Brazil: protocol for the CODE cohort.

Carlos Brites, Estela Luz, Cristiani Stelitano, Fabianna Bahia, Marcus Vinícius Guimarães de Lacerda, Aline Ramalho, Sandra Wagner Cardoso, Valdez Madruga, Tânia Reuter, Alexandre Naime Barbosa and 16 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Restoring well-being: quality of life improvements following dolutegravir-based therapy after antiretroviral failure.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Carlos BritesUniversidade Federal da Bahia/Fundação Bahiana de Infectologia, Salvador, Bahia, Brazil. crbrites@ufba.br.
Estela LuzUniversidade Federal da Bahia/Fundação Bahiana de Infectologia, Salvador, Bahia, Brazil.
Cristiani StelitanoUniversidade Federal da Bahia/Fundação Bahiana de Infectologia, Salvador, Bahia, Brazil.
Fabianna BahiaCentro Estadual Especializado em Diagnóstico Assistência e Pesquisa, Bahia, Brazil.
Marcus Vinícius Guimarães de LacerdaFundação de Medicina Tropical Tropical do Amazonas, Manaus, Amazonas, Brazil.
Aline RamalhoHospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil.
Sandra Wagner CardosoInstituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil.
Valdez MadrugaCentro de Referência e Tratamento DST/AIDS, São Paulo, Brazil.
Tânia ReuterHospital Universitário Cassiano Antônio de Moraes, Espirito Santo, Brazil.
Alexandre Naime BarbosaFaculdade de Medicina de Botucatu, Universidade Estadual Paulista, São Paulo, Brazil.
Rosa Dea SperhackFundação Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.
Monica Baumgardt BayDepartamento de Infectologia, Universidade Federal do Rio Grande do Norte, Natal, Brazil.
Tâmara NewmanInstituto de Infectologia Emílio Ribas, São Paulo, Brazil.
Karen MorejonHospital das Clínicas da Faculdade de Medicina de Ribeirao Preto, Universidade São Paulo, São Paulo, Brazil.
Maria PatelliSociedade Campineira de Educação e Instrução, São Paulo, Brazil.
Fábio LealUniversidade Municipal de São Caetano do Sul, São Paulo, Brazil.
Eduardo SprinzHospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
Cristina Murray-KrezanDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of America.
Mary CarmodyGillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
Jess AndersonDepartment of Internal Medicine, University of New Mexico Health Sciences Scenter, Albuquerque, NM, United States of America.
Alejandro AragonDepartment of Internal Medicine, University of New Mexico Health Sciences Scenter, Albuquerque, NM, United States of America.
Benjamin ChaseDepartment of Internal Medicine, University of New Mexico Health Sciences Scenter, Albuquerque, NM, United States of America.
Roberto ZajdenvergGSK Brazil, Rio de Janeiro, Brazil.
Bryn JonesViiV Healthcare, London, UK.
Fatima DutraDepartment of Internal Medicine, University of New Mexico Health Sciences Scenter, Albuquerque, NM, United States of America.
Kimberly PageDepartment of Internal Medicine, University of New Mexico Health Sciences Scenter, Albuquerque, NM, United States of America.

Funding

POPULATION STUDIEST32HD007168 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ELIZABETH A FRANKENBERG · 1985 to 2026
$13.8M
NICHD NIH HHS T32 HD007168
6 · The paper itself

Abstract

The Clinical Outcomes of Dolutegravir Treatment in People Living with HIV in Brazil (CODE) cohort study is a multicenter, prospective, observational study designed to evaluate the safety and efficacy of Dolutegravir (DTG)-based antiretroviral therapy (ART) among people living with HIV across diverse settings in Brazil. With the recent global shift towards DTG as a preferred option for first-line ART, particularly in low- and middle-income countries, there is vital need for comprehensive real-world data to inform its widespread use. CODE aims to fill this knowledge gap by assessing the clinical outcomes of both ART-naïve and ART-experienced patients initiating DTG-based regimens, as well as those who have switched from non-DTG-based ART. The primary objective of this study is to determine the proportion of patients who discontinue DTG due to any adverse events, specifically focusing on metabolic and psychiatric outcomes. Secondary objectives include evaluating the rates of virological suppression, the occurrence of immune reconstitution inflammatory syndrome (IRIS), changes in body mass index (BMI), and the development of HIV drug resistance. The CODE cohort will enroll approximately 5000 participants from multiple clinical sites across Brazil, including 2500 ART-naïve individuals, 1000 patients switching to DTG-based regimens for various reasons, and a comparator group of 1500 individuals who initiated non-DTG-based ART between 2013 and 2016, before DTG was available in the country. Participants will be followed for up to 36 months, with data collection points at baseline, 6, 12, 24, and 36 months. This study is expected to generate critical insights into the long-term outcomes associated with DTG-based ART, particularly in real-world settings that reflect the complexities of routine clinical care. By providing robust data on the effectiveness and safety of DTG in a diverse patient population, the CODE study aims to contribute to the optimization of HIV treatment strategies both in Brazil and globally.Key words: HIV-1, Dolutegravir, Outcomes, Brazil.

Indexed as

Anti-HIV AgentsHeterocyclic Compounds, 3-RingHIV InfectionsHIV Integrase InhibitorsAdultBrazilCohort StudiesDolutegravirFemaleHumansMaleMiddle AgedOxazinesPiperazinesProspective StudiesPyridonesAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsOxazinesPiperazinesPyridones

Identifiers

PMID41062955
PMCPMC12505586

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.