BIC CNS Study

Brain connectivity and patient reported outcomes in people with HIV (PWH) with symptoms of insomnia switching integrase inhibitor-based ART; a randomised controlled study - BIC CNS Study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004007-12-GB

Enrollment

Registered

2020-03-02

Start date

2020-06-02

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Interventions

Trade Name: Biktarvy Product Name: Biktarvy Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bictegravir Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - HIV-1 positive - age = 18 years - plasma HIV RNA 4 months - A total score of 8 or greater in the Insomnia Severity Index - BMI 18 - 32, inclusive Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Significant neurological disease - Current history of major depression or psychosis - Diagnosed sleep disorder (sleep apnoea, narcolepsy) - Current medication which is likely to interfere with sleep - Recent head injury (past 30 days) - Current alcohol abuse or drug of abuse dependence - Active opportunistic infection or significant co-morbidities - Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to look at changes in brain activity using a brain scan called functional magnetic resonance imaging (fMRI) whilst the participant is resting and whilst performing tasks. ;Secondary Objective: The secondary objectives are to look at: - Changes in patient reported outcomes - Associations between fMRI changes and changes in patient reported outcomes measurements - Changes in other brain imaging measures;Primary end point(s): Changes in MRI cerebral function parameters and patient reported outcomes between baseline and day 120.;Timepoint(s) of evaluation of this end point: Baseline & day 120	—

Measure

Time frame

Main Objective: The primary objective is to look at changes in brain activity using a brain scan called functional magnetic resonance imaging (fMRI) whilst the participant is resting and whilst performing tasks. ;Secondary Objective: The secondary objectives are to look at: - Changes in patient reported outcomes - Associations between fMRI changes and changes in patient reported outcomes measurements - Changes in other brain imaging measures;Primary end point(s): Changes in MRI cerebral function parameters and patient reported outcomes between baseline and day 120.;Timepoint(s) of evaluation of this end point: Baseline & day 120

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Countries

United Kingdom

Contacts

Public ContactNicki Doyle

Imperial College London - International HIV Clinical Trials Research Management Office

n.doyle@imperial.ac.uk02033121670

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026