Status:
RECRUITING
Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil
Lead Sponsor:
Fundação Bahiana de Infectologia
Collaborating Sponsors:
University of New Mexico
Instituto Infectologia Evandro Chagas, Rio de Janeiro
Conditions:
HIV Infections
Clinical Outcomes
Eligibility:
All Genders
18+ years
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 r...
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...
Eligibility Criteria
Inclusion
- • 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
- • Any previous use of ART (drug-naïve group only).
- Current imprisonment, or compulsory detention (involuntary incarceration). For treatment of a psychiatric or physical illness.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04326504
Start Date
February 1 2021
End Date
February 28 2025
Last Update
February 26 2024
Active Locations (3)
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1
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, Brazil, 40010-160
2
Fundação Bahiana de Infectologia
Salvador, Estado de Bahia, Brazil, 40110160
3
Centro de Referência e Treinamento
São Paulo, São Paulo, Brazil, 04121-000