Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

R01AG048650

The aim of this study is to test whether tesamorelin, in combination with a text-messaging application to help with motivation and adherence, will significantly improve memory and thinking in HIV.

2017-02-15

2023-10-15

2023-10-15

Completed

Early phase I

73

Inclusion Criteria: * HIV-1 infection documented by any FDA licensed clinical test including HIV enzyme/antigen test or chemiluminescence immunoassay (E/CIA) or plasma HIV-1 RNA viral load. * Antiretroviral therapy: Patient currently receiving a combination antiretroviral therapy (cART) regimen ≥12 weeks with no interruptions longer than 7 days and HIV \<500 copies/ml during that time. * Men or women 40 years of age and older * Abdominal minimal waist circumference ≥ 95cm for men and ≥94cm for women or minimal waist to hip ratio of ≥ 0.88 for women (each based on an average of three separate measurements) * Screening neuropsychological Global Deficit Score of ≥ 0.35 * The following laboratory values obtained within 90 days prior to entry by any CLIA certified laboratory. * Absolute neutrophil count (ANC) ≥750/mm3 * Hemoglobin ≥8.0 g/dL * Platelet count ≥50,000/mm3 * HgbA1C ≤8.0% * Calculated creatinine clearance of ≥20 mL/min as estimated by the Cockroft-Gault formula * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT) \<5 X upper limit of normal (ULN) and alkaline phosphatase \<3 X upper limit of normal (ULN) without evidence of active liver disease other than non-alcoholic fatty liver disease (NAFLD) or hepatitis C requiring treatment. * Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is acceptable). * For females of reproductive potential, negative serum or urine pregnancy test within 30 days prior to entry by any test performed by a CLIA certified laboratory or is using a point of care (POC)/ CLIA-waived test. * Contraception requirements: For females of reproductive potential, she or male partner is willing to use a contraceptive during sexual intercourse. * Ability and willingness of participant or legal guardian/representative to provide informed consent Exclusion Criteria: * Clinical contraindications * History of neurocognitive confounding conditions that explain current impairment including but not limited to stroke, head injury, psychotic disorder, active substance use disorder by DSM, or opportunistic CNS infection * Hepatitis C virus infection defined as HCV antibody positive requiring treatment and plans for treatment during study therapy * Active or relapsing autoimmune disorder that may require immunotherapy during this treatment trial * Active malignancy other than basal or squamous skin cancer. * Breastfeeding or pregnancy * Excluded medications used within the last 90 days: active or planned use of rhGH, anabolic steroids (other than replacement doses of testosterone), anti-TNFa therapy or other biologic (tocilizumab, Xelijanz, etc.) * Anticipated need to start new daily anti-inflammatory therapy such as NSAIDs (excluding aspirin for vascular prophylaxis), systemic corticosteroids, or anti-malarials, or plan to discontinue regular dosing with these drugs during study treatment. * Known allergy/sensitivity or any hypersensitivity to tesamorelin * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to entry * Use of tesamorelin in the last 6 months

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2024-05-06