Mild Cognitive Impairment Clinical Trial
Official title:
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Verified date | May 2024 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | October 15, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | PalmTree Clinical Research Inc., University of California, San Francisco, University of Southern California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognitive performance | Change in neurocognitive performance measured by Global Deficit Score (GDS) | 6 months and 12 months | |
Secondary | Biomarkers of visceral adipose tissue (VAT)-related inflammation and immune activation, metabolic parameters, and neuronal integrity | Change in IGF-1, magnetic resonance spectroscopy measures of brain inflammation/immune activation and hippocampal volume | 6 months |
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