A study looking at the effects of switching anti-HIV therapy in people with HIV who have difficulty sleeping

Phase 4

Completed

• Conditions: Human immunodeficiency virus [HIV] disease; Infections and Infestations

• Registration Number: ISRCTN17508886
• Lead Sponsor: niversity of Sussex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-23
• Study Completion: 2023-05-11
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Current participant inclusion criteria as of 16/06/2022:
1. HIV-1 positive
2. Age =18 years
3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
5. On a stable antiretroviral regimen comprising of dolutegravir plus either one or two NRTIs once daily for >4 months
6. A total score of =8 on the Insomnia Severity Index
7. BMI =18

Previous participant inclusion criteria as of 03/03/2022:
1. HIV-1 positive
2. Age =18 years
3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
5. On a stable antiretroviral regimen comprising of dolutegravir plus either one or two NRTIs once daily for >4 months
6. A total score of =8 on the Insomnia Severity Index
7. BMI of 18-32, inclusive

Previous participant inclusion criteria as of 17/06/2021:
1. HIV-1 positive
2. Age =18 years
3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
5. On a stable antiretroviral regimen comprising of Triumeq™ once daily for >4 months
6. A total score of =8 on the Insomnia Severity Index
7. BMI of 18-32, inclusive

Previous participant inclusion criteria:
1. HIV-1 positive
2. Age > = 18 years
3. Plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
5. On a stable antiretroviral regimen comprising of Triumeq™ once daily for > 4 months
6. A total score of 8 or greater in the Insomnia Severity Index
7. BMI 18 - 32, inclusive

Exclusion Criteria

1. Significant neurological disease
2. Current history of major depression or psychosis
3. Diagnosed sleep disorder (sleep apnoea, narcolepsy)
4. Current medication which is likely to interfere with sleep
5. Recent head injury (past 30 days)
6. Current alcohol abuse or drug of abuse dependence
7. Active opportunistic infection or significant co-morbidities
8. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified