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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: PalmTree Clinical Research Inc.; University of California, San Francisco; University of Southern California
• Treatments: Growth Hormone-Releasing Hormone; Tesamorelin

Criteria

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