Clinical trial NCT04326504: Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil
Official title: Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Clinical Outcomes
Adverse Drug Event
Effect of Drugs
Lead sponsor: Fundação Bahiana de Infectologia
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Instituto Infectologia Evandro Chagas, Rio de Janeiro
name: Fundação de Medicina Tropical de Manaus
name: Hospital de Clinicas de Porto Alegre
name: Centro de Referência e Tratamento, CRT, São Paulo, SP
name: Hospital Partenon, Porto Alegre
name: Universidade Municipal de São Caetano do Sul
name: Universidade Federal do Rio Grande do Norte
name: Hospital Universitário Cassiano Antônio de Moraes/HUCAM
name: Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto/USP
name: Faculdade de Medicina de Botucatu, Unesp
name: Sociedade Campineira de Educação e Instrução - Campinas
name: Fundação Universidade de Caxias do Sul - FUCS/RS
First posted: 2020-03-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

Brief 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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • Any previous use of ART (drug-naïve group only).

  * Current imprisonment, or compulsory detention (involuntary incarceration). For treatment of a psychiatric or physical illness.

Primary outcomes:
measure: frequency of therapy discontinuation due to any event for patients starting ART
timeFrame: 36 months
measure: therapy discontinuation due to any event for ART-eprerienced patients starting DTG-based regimens
timeFrame: 36 months
Secondary outcomes:
measure: Exploratory outcomes
timeFrame: 36 months
measure: Changes in quality of life for patients switching to DTG-based regimens
timeFrame: 6 and 12 months
measure: HIV drug resistance
timeFrame: 36 months
measure: Markers of CVD risk
timeFrame: 36 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Fundação Bahiana de Infectologia/SEI
state: Bahia
city: Salvador
country: Brazil
facility: Fundação Bahiana de Infectologia
state: BA
city: São Paulo
country: Brazil
facility: Centro de Referência e Treinamento
state: SP
Study officials:
References:
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citation: Cruz LN, Fleck MP, Oliveira MR, Camey SA, Hoffmann JF, Bagattini AM, Polanczyk CA. Health-related quality of life in Brazil: normative data for the SF-36 in a general population sample in the south of the country. Cien Saude Colet. 2013 Jul;18(7):1911-21. doi: 10.1590/s1413-81232013000700006.
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