Study Results
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Basic Information
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COMPLETED
1433 participants
OBSERVATIONAL
2020-02-10
2021-05-20
Brief Summary
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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.
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Detailed Description
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BACKGROUND: DTG is a second-generation integrase strand transfer inhibitor with 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. Though some cases have been described, HIV-1 resistance to DTG is rare in clinical settings when DTG is used as part of a combination therapy. The use of DTG in first-line antiretroviral therapy (ART) regimens was recommended by the World Health Organisation in 2018 and was adopted by the Ministry of Health in Lesotho in 2019. DTG now forms part of the recommended first-line therapy for many ART-naïve patients in Lesotho. In addition, many patients on a non-DTG-based first-line ART regimen will be transitioned to a DTG-based regimen.
OBJECTIVES: Despite the positive health outcomes observed in patients receiving DTG-based ART in high-income countries and in clinical trial settings, there is little data on virologic outcomes of patients on DTG during large-scale implementation in low- and lower middle-income countries. Concerns remain regarding the risk that some patients transitioning to a DTG-based regimen will be placed on a functional monotherapy. Furthermore, there are concerns as to psychological side-effects and observed weight gain. This observational study aims to assess the virologic outcomes (viral suppression rates as well as potential drug resistance) as well as side-effects of people living with HIV-1 and transitioning to a DTG-based ART regimen in Lesotho.
DO-REAL has two major objectives:
* To assess virologic outcomes after the programmatic shift to DTG-based regimens.
* To assess psychological and somatic wellbeing in patients before and after the programmatic shift to DTG-based regimens.
METHODS: DO-REAL is a cohort study enrolling people living with HIV who are initiating or are eligible (according to national guidelines and the local implementation thereof) to initiate a DTG-based antiretroviral therapy (ART) regimen. The study will take place at three hospitals in two districts (Butha-Buthe, Mokhotlong) in Lesotho, and aims to enrol over 2000 participants. Viral loads will be measured on the day of initiating a DTG-based regimen (or on the day this was offered), as well as four, 12 and 24 months thereafter. In a post-hoc analysis, samples will be tested for drug resistance in samples where the viral load permits (approx. ≥100 c/mL). A subset of participants will complete screenings for depression, general health, and HIV-related symptoms.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV-1-positive individuals
HIV-1-positive individuals eligible to receive a DTG-based ART regimen at enrolment.
Dolutegravir
Eligibility to receive DTG-based ART at enrolment (i.e., initiation or offer to initiate DTG-based ART)
Interventions
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Dolutegravir
Eligibility to receive DTG-based ART at enrolment (i.e., initiation or offer to initiate DTG-based ART)
Eligibility Criteria
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Inclusion Criteria
* Initiating or eligible to initiate (offered to initiate) a DTG-based ART regimen
* Informed written consent (and assent, if applicable) provided
Exclusion Criteria
ALL
No
Sponsors
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SolidarMed
OTHER
Ministry of Health, Lesotho
OTHER_GOV
District Health Management Team of Butha-Buthe, Lesotho
OTHER
District Health Management Team of Mokhotlong, Lesotho
OTHER
University of Basel
OTHER
Swiss Tropical & Public Health Institute
OTHER
Responsible Party
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Principal Investigators
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Niklaus D Labhardt, MD, MIH
Role: STUDY_CHAIR
Swiss Tropical & Public Health Institute
Thomas Klimkait, PhD
Role: STUDY_DIRECTOR
University of Basel
Josephine Muhairwe, MD, MPH
Role: STUDY_DIRECTOR
SolidarMed
Jennifer A Brown, MSc, MAS D&C
Role: PRINCIPAL_INVESTIGATOR
Swiss Tropical & Public Health Institute
Locations
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Butha-Buthe Government Hospital
Butha-Buthe, , Lesotho
Seboche Mission Hospital
Butha-Buthe, , Lesotho
Countries
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References
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Brown JA, Nsakala BL, Mokhele K, Rakuoane I, Muhairwe J, Urda L, Amstutz A, Tschumi N, Klimkait T, Labhardt ND. Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor- to dolutegravir-based antiretroviral therapy: A prospective cohort study in Lesotho (DO-REAL study). HIV Med. 2022 Mar;23(3):287-293. doi: 10.1111/hiv.13189. Epub 2021 Oct 10.
Brown JA, Nsakala BL, Mokhele K, Rakuoane I, Muhairwe J, Glass TR, Amstutz A, Tschumi N, Belus JM, Klimkait T, Labhardt ND. Dolutegravir in real life: Self-reported mental and physical health outcomes after transitioning from efavirenz- to dolutegravir-based antiretroviral therapy in a prospective cohort study in Lesotho. HIV Med. 2023 Feb;24(2):153-162. doi: 10.1111/hiv.13352. Epub 2022 Jun 22.
Study Documents
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Document Type: Individual Participant Data Set
Dataset relating to: Brown JA, Nsakala BL, Mokhele K, et al. Dolutegravir in real life: Self-reported mental and physical health outcomes after transitioning from efavirenz- to dolutegravir-based antiretroviral therapy in a prospective cohort study in Lesotho. HIV Med. Published online June 22, 2022. doi:10.1111/hiv.13352
View DocumentDocument Type: Individual Participant Data Set
Dataset relating to: Brown JA, Nsakala BL, Mokhele K, et al. Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor- to dolutegravir-based antiretroviral therapy: A prospective cohort study in Lesotho (DO-REAL study). HIV Med. 2022;23(3):287-293. doi:10.1111/hiv.13189
View DocumentOther Identifiers
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P001-19-1.2
Identifier Type: -
Identifier Source: org_study_id
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