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Dolutegravir in Real Life in Lesotho

NCT04238767 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1433

Last updated 2023-05-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dolutegravir

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

Sponsors & Collaborators

  • SolidarMed

    collaborator OTHER

  • Ministry of Health, Lesotho

    collaborator OTHER_GOV

  • District Health Management Team of Butha-Buthe, Lesotho

    collaborator OTHER

  • District Health Management Team of Mokhotlong, Lesotho

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Niklaus D Labhardt, MD, MIH · Swiss Tropical & Public Health Institute

  • Thomas Klimkait, PhD · University of Basel

  • Josephine Muhairwe, MD, MPH · SolidarMed

  • Jennifer A Brown, MSc, MAS D&C · Swiss Tropical & Public Health Institute

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-05-19
Completion
2021-05-20

Countries

  • Lesotho

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238767 on ClinicalTrials.gov