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

Completed · Phase 2

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02572323

Run by

University of California, San Diego

People needed

73

Starts

2017-02-15

Expected to finish

2023-10-15

Last updated by the study team

2026-03-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Keck School of Medicine of the University of Southern California — Los Angeles, California, United States
• PalmTree — Palm Springs, California, United States
• HIV Neurobehavioral Research Program (HNRP) — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.