Borrego Health is involved in several research studies involving several disciplines. This is an area of investigation for new treatment protocols and advancements leading to improved health outcomes for our patients.
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.