Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study investigators will use a multi-modal imaging approach of MRS and fMRI to comprehensively assess the biological changes in the brain associated with EFV-based regimen (EFV/FTC/TDF), specifically alterations in the brain circuitry, function and local neurochemistry, and their correlation with neuropsychological function.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Raltegravir Potassium

Criteria

Inclusion Criteria:

1. Chronic HIV-infected individuals on suppressive regimen with EFV/FTC/TDF, for at least 6 months

2. Undetectable HIV-1 RNA virus load for at least 6 months

3. No co-infections with active hepatitis B and C

4. Presence of at least moderate symptoms on 2 out of 3 subcores on the DASS

5. No known active HIV-related and non-HIV related CNS infections

6. Estimated glomerular filtration rate (EGFR) >60 ml/min

7. Consent to switching to EVG/COBI/FTC/TDF

8. Ages 18 - 65

Exclusion Criteria:

1. History of CNS opportunistic infections or active CNS infections

2. History of severe psychiatric disorder (excluding depression and anxiety)

3. History of chronic neurological disorders, such as epilepsy or multiple sclerosis

4. History of or current significant substance abuse or dependence and/or heavy alcohol use (>12 oz/wk)

5. Any women who may be pregnant (positive urine pregnancy test or unprotected sex in 2 weeks prior to scan) or known to be pregnant

6. Contraindications to undergoing fMRI, including metallic implants, claustrophobia, and medical conditions or medications that significantly affect cerebral blood flow or function.