BIC CNS Study

Phase 1

• Conditions: HIV infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-004007-12-GB
• Lead Sponsor: niversity of Sussex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

- HIV-1 positive
- age = 18 years
- plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
- acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- On a stable antiretroviral regimen comprising of Triumeq™ once daily for >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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified