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

Completed · Not applicable

Conditions studied: HIV, HIV-associated Neurocognitive Disorder, Neurotoxicity

In brief

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.

Key facts

Study ID

NCT01978743

Run by

Massachusetts General Hospital

People needed

10

Starts

2014-01-01

Expected to finish

2017-01-01

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HIV-infected individuals on suppressive regimen with EFV/FTC/TDF, for at least 6 months
• Undetectable HIV-1 RNA virus load for at least 6 months
• No co-infections with active hepatitis B and C
• Presence of at least moderate symptoms on 2 out of 3 subcores on the DASS
• No known active HIV-related and non-HIV related CNS infections
• Estimated glomerular filtration rate (EGFR) >60 ml/min
• Consent to switching to EVG/COBI/FTC/TDF
• Ages 18 - 65

You may not qualify if…

• History of CNS opportunistic infections or active CNS infections
• History of severe psychiatric disorder (excluding depression and anxiety)
• History of chronic neurological disorders, such as epilepsy or multiple sclerosis
• History of or current significant substance abuse or dependence and/or heavy alcohol use (>12 oz/wk)
• Any women who may be pregnant (positive urine pregnancy test or unprotected sex in 2 weeks prior to scan) or known to be pregnant
• Contraindications to undergoing fMRI, including metallic implants, claustrophobia, and medical conditions or medications that significantly affect cerebral blood flow or function.

Where it is running

• Brigham and Women's hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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