Obesity and Health Thinking Study
The central goals of this study are:
Determine if 6-months of treatment with tesamorelin (Tes) administered in combination with a behavioral approach to maintaining adherence will significantly improve neurocognitive performance when compared to a control group.
Evaluate mechanisms by which tesamorelin fosters improved cognition by measuring changes in VAT-volume and changes in brain scan activities.
Maintaining brain and cognitive health is a key target for improving health outcomes and quality of life as HIV+ individuals age. HIV-associated neurocognitive disorders (HAND) remain an important and significant complication of HIV, affecting almost 50% of HIV+ persons. This study seeks to determine if 6-months of treatment with tesamorelin (Tes) administered in combination with a behavioral approach to maintaining adherence will significantly improve neurocognitive performance versus no treatment.
This is a 1-year study involving multiple sites. Each participant will have a total of 11 study visits.
DESIGN: Phase 2, parallel groups, randomized 3:2 to active vs deferred treatment (active: placebo) randomized study
DURATION: 6 months primary either during Period A or Period B
SAMPLE SIZE: 100
POPULATION: HIV+ individuals with abdominal obesity, well-controlled HIV infection, and a minimum level of neurocognitive impairment on cognitive tests
REGIMEN OR INTERVENTION (as required): Tesamorelin (Egrifta) 2mg subcutaneous injection daily for 6 months as monitored by a novel text system.
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