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NOT YET RECRUITING
NCT07673965
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.