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

NCT07673965 | Not Yet Recruiting Phase 4

• 2 other identifiers: EZ-TC-041103974
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV (Human Immunodeficiency Virus); Sleep

Keywords

Delstrigo:; Sleep Health; Sleep Architecture; Antiretroviral Therapy; HIV

Outcome Measures

Primary Outcomes (1)

• Change in RU-SATED total score from baseline to week 12

  RU-SATED Questionnaire (Total Score: 0-24) Sleep health will be assessed using the RU-SATED sleep health questionnaire, a validated multidimensional measure comprising six domains of sleep health: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Each domain is scored on a scale of 0-4, with higher scores indicating better sleep health. The total score ranges from 0 to 24, with higher scores reflecting overall better sleep health. The six items are as follows: Regularity: I go to sleep and wake up at about the same time every day. Duration: I sleep 7-9 hours per night. Timing: The midpoint of my sleep period is between 2:00 a.m. and 4:00 a.m. Efficiency: I am awake for less than 30 minutes between the time I go to bed and the time I get out of bed. Alertness: I stay awake all day without dozing. Satisfaction: I am satisfied with my sleep.

  Baseline and Week 12

Secondary Outcomes (15)

• Between-Arm Difference in RU-SATED Total Sleep Health Score at Week 12

  Week 12

• Change from Baseline to Week 12 in Polysomnography-Derived Sleep Stage Distribution (N1, N2, N3, REM)

  Baseline and Week 12

• Change from Baseline to Week 12 in Polysomnography-Derived Sleep Latency

  Baseline and Week 12

• Change from Baseline to Week 12 in Polysomnography-Derived REM Latency

  Baseline and Week 12

• Change from Baseline to Week 12 in Polysomnography-Derived Total Sleep Time

  Baseline and Week 12

Other Outcomes (10)

• Internal consistency of the RU-SATED questionnaire measured by Cronbach's alpha

  Baseline and Week 12

• Correlation between RU-SATED score and PROMIS Sleep Disturbance SF 8a

  Baseline and Week 12

• Sleep Duration Measured by Actigraphy at Baseline and Week 12

  Baseline and Week 12

Study Arms (2)

TDF/3TC/DTG Arm

ACTIVE COMPARATOR

Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg (TDF/3TC/DTG; TLD) is the recommended first-line antiretroviral regimen for adults weighing ≥30 kg, according to the South African National ART Guidelines (2026). Participants randomised to continue TLD will serve as the control arm.

Drug: Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg

TDF/3TC/DOR Arm

EXPERIMENTAL

DELSTRIGO (TDF/3TC/DOR) 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.

Drug: Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg

Interventions

Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg DRUG

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.

Also known as: Delstrigo

TDF/3TC/DOR Arm

Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg DRUG

Tenofovir disoproxil fumarate 300mg /lamivudine 300mg /dolutegravir 50mg (fixed dose combination tablet) one tab taken orally daily for the duration of the study.

Also known as: TLD

TDF/3TC/DTG Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• 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
• 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
• Use of medications known to significantly alter sleep, including (but not limited to):
• Benzodiazepines
• Non-benzodiazepine sedative-hypnotics
• Antipsychotics or mood stabilisers

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Lamivudine; doravirine; dolutegravir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Francois WD Venter, PhD

  Ezintsha, a division of Wits Health Consortium

  STUDY DIRECTOR

Central Study Contacts

Bukani X Dyariwe

CONTACT

+27110844961; bdyariwe@ezintsha.org

Tarryn Collings, MBChB

CONTACT

+27110844982; tcollings@ezintsha.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Delstrigo: (Oral daily) Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and doravirine 100 mg (TDF/3TC/DOR) TLD (Acriptega): (Oral daily) Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg (TDF/3TC/DTG)

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication
• Access Criteria: Anyone who wishes to access the data