Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Witwatersrand, South Africa

About this trial

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.

Eligibility criteria

Qualifiers

Male or female aged 18-40 years

HIV-positive

Virologically suppressed, defined as HIV RNA <50 copies/mL

No known history of HIV treatment failure

Disqualifiers

Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable

Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)

Previous NNRTI use or prior documented NNRTI mutations

Clinical suspicion of TB

Trial design

Treatments tested in this trial

  • Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg
  • Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations