Clinical trial

Observational Assessment of the Nation-wide Roll-out of Dolutegravir in Lesotho

Name

P001-19-1.2

Description

DO-REAL is an observational cohort study assessing the large-scale roll-out of the antiretroviral drug dolutegravir (DTG) in Lesotho. DTG has been shown to have low side-effects and superior treatment outcomes for people living with HIV-1 when compared to other antiretroviral drugs currently in use in low-income countries. The use of DTG in first-line antiretroviral therapy (ART) regimens was recommended by the World Health Organisation in 2018 and adopted by the Ministry of Health in Lesotho in 2019. While DTG-based ART regimens have led to promising health outcomes in high-income and clinical trial settings, certain concerns remain regarding the risk of ART-experienced patients transitioning to a DTG-based ART regimen being placed on a functional monotherapy (increasing the otherwise low risk of viral resistance to DTG) as well as side-effects including psychological symptoms and weight gain. Thus, the DO-REAL study intends to address these concerns and provide data on health outcomes of HIV patients on DTG in a "real-life" high-prevalence setting.

Trial arms

Trial start

2020-02-10

Estimated PCD

2021-05-19

Trial end

2021-05-20

Status

Completed

Treatment

Dolutegravir

Eligibility to receive DTG-based ART at enrolment (i.e., initiation or offer to initiate DTG-based ART)

Arms:

HIV-1-positive individuals

Size

1433

Primary endpoint

Virologic outcomes after programmatic transition to DTG-containing regimens

4 months after initiation of a DTG-containing regimen

Quality of life screening score (change from baseline)

Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter

Depression screening score (change from baseline)

Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter

HIV symptom screening score (change from baseline)

Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter

Eligibility criteria

Inclusion Criteria: * HIV-1-positive * Initiating or eligible to initiate (offered to initiate) a DTG-based ART regimen * Informed written consent (and assent, if applicable) provided Exclusion Criteria: * None

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma'}, 'enrollmentInfo': {'count': 1433, 'type': 'ACTUAL'}}

Updated at

2023-05-23

1 organization

1 product

1 indication

Organization

Swiss Tropical & Public Health Institute

Product

Dolutegravir

Indication

HIV-1 infection