NCT07673965Not yet recruitingPhase 4
Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIV
Multidimensional Sleep Health in People Living With HIV on Dolutegravir-Based Versus Doravirine-Based Antiretroviral Therapy: A Pilot Study
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 May 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- University of Witwatersrand, South Africa
- Diseases
- HIV
- NCT number
- NCT07673965
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 5 Oct 2026 to the primary completion date, 31 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable
- Previous NNRTI use or prior documented NNRTI mutations
- Use of medications known to significantly alter sleep, including (but not limited to):
- Benzodiazepines
- Non-benzodiazepine sedative-hypnotics
- Antipsychotics or mood stabilisers
- Antidepressants with significant sedating effects
- Isoniazid
- Anticonvulsants e.g. carbamazepine, phenytoin, phenobarbital
Other illness
- Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)
- Insufficient total sleep time on screening polysomnography to permit reliable interpretation of sleep parameters or to confirm or exclude a sleep disorder.
- Evidence of a clinically significant sleep disorder at screening, based on history, the site-specific Sleep Disorders Screening Tool (SDST) and/or polysomnography, including but not limited to:
- Suspected or confirmed OSA
- Suspected or known insomnia
- Suspected restless legs syndrome (RLS), or periodic limb movements on PSG
- Narcolepsy
- Current alcohol use disorder or substance use (including illicit substances) that may interfere with sleep or study assessments, as determined by the investigator.
- Active psychiatric illness that might interfere with study procedures or overnight assessments, as assessed by the investigator
- Known or suspected significant neurological conditions that may interfere with sleep (e.g., epilepsy, neurodegenerative disorders, or a history of moderate-to-severe traumatic brain injury).
Age
- Pregnant, breastfeeding, or planning to become pregnant during the study period, or currently nursing or caring for an infant younger than 6 months at home
Other
- \-
- Participants meeting any of the following criteria will be excluded from the study:
- Clinical suspicion of TB
- Regular shift work defined as working more than three nights or rotating shifts per month at baseline or during the study, or having transitioned from night-shift to day-shift duties within the past month
- Current participation in another clinical trial, observational or interventional
Who the study is looking for
- \-
- Each participant must meet all the following criteria to be enrolled in this study:
- 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
- On a stable first-line ART regimen for ≥ 12 months and TDF/3TC/DTG for ≥ 6 months prior to enrolment
- BMI \< 35 kg/m² and weight \>35kg
- Women of childbearing potential must have a negative pregnancy test at screening, must use acceptable contraception throughout the study, and must not be planning pregnancy during the study period
- Willing and able to undergo overnight PSG as required by the protocol
- Clinically stable with no uncontrolled comorbidities as assessed by the investigator
- Able and willing to provide written informed consent
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.