N/A
N=10
Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen
HIV · HIV-associated Neurocognitive Disorder · Neurotoxicity
Bottom Line
View on ClinicalTrials.gov: NCT01978743 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) — 19.38; 18.94; 27.83; 24.95 arbitrary units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Raltegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) |
19.38; 18.94; 27.83; 24.95; 5.27; 5.32 | — |
| PRIMARY Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI) |
3.19; 3.00; -2.53; -3.64; 4.01; 3.61 | — |
| SECONDARY Other Neurometabolite Changes Measured by MRS |
5.11; 4.70; 4.32; 3.31; 4.25; 3.18 | — |
| SECONDARY Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI |
48.1; 53.5; 79.2; 72.4; 4.7; 2.7 | — |
| SECONDARY Fasting Lipid Profile |
200.9; 176.7; 58.8; 53.1; 118.8; 103.5 | — |
| SECONDARY Sleep Quality |
5.3; 3.8 | — |
| SECONDARY ART Regimen Preference |
7; 0; 3 | — |
| SECONDARY Markers of Immune Activation |
3652333.6; 3135828.52; 195.84; 202.85; 672844; 733536 | — |
| SECONDARY Change in Level of EFV and Metabolites |
9; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01978743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.