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Could HIV treatment choice affect sleep? new study investigates

NCT ID NCT07673965

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study looks at sleep health in people with HIV who are on different antiretroviral therapies. Some participants switch from a dolutegravir-based regimen to a doravirine-based one, while others stay on dolutegravir. Sleep is measured using questionnaires, wrist-worn activity monitors, and overnight sleep studies. The goal is to see if the type of HIV medication affects sleep quality and patterns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Doravirine (Delstrigo) and dolutegravir-based antiretroviral therapy
What this could lead to
If differences in sleep health are found, this could help tailor HIV treatment to improve quality of life and long-term health.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply broadly. Sleep changes may be subtle or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Each participant must meet all the following criteria to be enrolled in this study: 1. Male or female aged 18-40 years 2. HIV-positive 3. Virologically suppressed, defined as HIV RNA \<50 copies/mL 4. No known history of HIV treatment failure 5. On a stable first-line ART regimen for ≥ 12 months and TDF/3TC/DTG for ≥ 6 months prior to enrolment 6. BMI \< 35 kg/m² and weight \>35kg 7. 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 8. Willing and able to undergo overnight PSG as required by the protocol 9. Clinically stable with no uncontrolled comorbidities as assessed by the investigator 10. Able and willing to provide written informed consent Exclusion Criteria: \- Participants meeting any of the following criteria will be excluded from the study: 1. Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable 2. Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers) 3. Previous NNRTI use or prior documented NNRTI mutations 4. Clinical suspicion of TB 5. Insufficient total sleep time on screening polysomnography to permit reliable interpretation of sleep parameters or to confirm or exclude a sleep disorder. 6. 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: 1. Suspected or confirmed OSA 2. Suspected or known insomnia 3. Suspected restless legs syndrome (RLS), or periodic limb movements on PSG 4. Narcolepsy 7. Use of medications known to significantly alter sleep, including (but not limited to): 1. Benzodiazepines 2. Non-benzodiazepine sedative-hypnotics 3. Antipsychotics or mood stabilisers 4. Antidepressants with significant sedating effects 5. Isoniazid 6. Anticonvulsants e.g. carbamazepine, phenytoin, phenobarbital 8. Current alcohol use disorder or substance use (including illicit substances) that may interfere with sleep or study assessments, as determined by the investigator. 9. 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 10. Active psychiatric illness that might interfere with study procedures or overnight assessments, as assessed by the investigator 11. 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 12. 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). 13. Current participation in another clinical trial, observational or interventional

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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