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

This is an interventional treatment trial for Mild Cognitive Impairment Read More

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