The CNS Integrase Inhibitor Study

Phase 1

• Conditions: Human Immunodificiency Virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003710-84-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-04
• Study Completion: 2016-08-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

HIV-1 infected subjects
Signed informed consent
No contraindication to lumbar puncture examination on screening MRI of brain.
Plasma HIV RNA < 200 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 for >4 months comprising of:
raltegravir 400mg twice daily
tenofovir 245 mg daily
emtricitabine 200 mg daily

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Existing neurological disease
Current history of major depression or psychosis
Recent head injury (past three months)
Current alcohol abuse or drug dependence
Active opportunistic infection or significant co-morbidities
Pregnancy

Study & Design

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