Clinical Research Directory
Browse clinical research sites, groups, and studies.
Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens
Sponsor: University of Witwatersrand, South Africa
Summary
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 therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.
Official title: Multidimensional Sleep Health in PLWH on DTG- vs DOR-Based ART: A Mixed-Methods Pilot Study
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-08-20
Completion Date
2027-11-30
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg
DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor \[NNRTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV infection in adults and adolescent individuals weighing at least 35 kg. One tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate. Participants will be required to take one tablet PO daily for the duration of the study.
Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg
Tenofovir disoproxil fumarate 300mg /lamivudine 300mg /dolutegravir 50mg (fixed dose combination tablet) one tab taken orally daily for the duration of the study.