Phase 4Not yet recruiting
Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIV (SOMNART)
Multidimensional Sleep Health in People Living With HIV on Dolutegravir-Based Versus Doravirine-Based Antiretroviral Therapy: A Pilot Study
- Sponsor
- University of Witwatersrand, South Africa (Academic or other)
- Enrolment
- 40 planned
- Conditions
- HIV (Human Immunodeficiency Virus); Sleep
- Interventions
- Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg; Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg
- Ages
- adults
- Registry
- NCT07673965
Full record on ClinicalTrials.gov
From the registry
In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based…
Primary outcomes
- Change in RU-SATED total score from baseline to week 12
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered