Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil (CODE)

Fundação Bahiana de Infectologia

Status: Enrolling

Conditions: Adverse Drug Event; Effect of Drugs; HIV Infections; Clinical Outcomes

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04326504

FBAI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 4 patient groups

Patients starting DTG-based regimens

Description:

ART-naïve patients, starting cART regimens based on DTG

Treatment:

Other: No intervention

Switch cohort

Description:

Patients on stable ART regimens switching to DTG (any reason)

Treatment:

Other: No intervention

Therapy failure

Description:

ART-experienced patients switching to DTG-containing regimens due to virological failure

Treatment:

Other: No intervention

Non-DTG group

Description:

Patients who started a non-DTG containing regimen

Treatment:

Other: No intervention