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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • Signed informed consent.

‣ HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.

⁃ Age ≥ 15 years.

⁃ For women of child-bearing potential, willingness to use effective contraceptives.

⁃ Starting use of DTG-based regimen, or being initiated on a non-DTG based ART between 2014 - 2016.

Locations
Other Locations
Brazil
Fundação Bahiana de Infectologia
RECRUITING
Salvador
Fundação Bahiana de Infectologia/SEI
RECRUITING
Salvador
Centro de Referência e Treinamento
RECRUITING
São Paulo
Contact Information
Primary
Carlos Brites, MD, PhD
crbrites@gmail.com
557132838123
Backup
Estela Luz, RN, MPH
eluz5@yahoo.com.br
557132838123
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 5000
Treatments
Patients starting DTG-based regimens
ART-naïve patients, starting cART regimens based on DTG
Switch cohort
Patients on stable ART regimens switching to DTG (any reason)
Therapy failure
ART-experienced patients switching to DTG-containing regimens due to virological failure
Non-DTG group
Patients who started a non-DTG containing regimen
Related Therapeutic Areas
Sponsors
Collaborators: University of New Mexico, Centro de Referência e Tratamento, CRT, São Paulo, SP, Universidade Municipal de São Caetano do Sul, Universidade Federal do Rio Grande do Norte, Fundação de Medicina Tropical de Manaus, Sociedade Campineira de Educação e Instrução - Campinas, Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto/USP, Faculdade de Medicina de Botucatu, Unesp, Hospital Partenon, Porto Alegre, Instituto Infectologia Evandro Chagas, Rio de Janeiro, Hospital de Clinicas de Porto Alegre, Hospital Universitário Cassiano Antônio de Moraes/HUCAM, Fundação Universidade de Caxias do Sul - FUCS/RS
Leads: Fundação Bahiana de Infectologia

This content was sourced from clinicaltrials.gov

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