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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
73 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
15 Feb 2017
Primary completion
15 Oct 2023
Completion
15 Oct 2023
First posted
8 Oct 2015 (estimated)
Last update posted
12 Mar 2026
Conditions
Mild Cognitive Impairment

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 2

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

    NCT02572323

    15 Feb 2017 to 15 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TesamorelinDrug

Arms2

  • Active comparator

    Immediate group

    1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months

  • Placebo comparator

    Deferred group

    No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Neurocognitive Performance

    Time frame · Baseline and week 24

    Registry description

    The primary outcome was neurocognitive (NC) change, measured by the summary regression-based change score (sRCS), derived from a comprehensive battery assessing seven NC domains using the Global Deficit Score (GDS). The sRCS is calculated as a z-score from regression model residuals between baseline and week 24, adjusting for practice effects, statistical artifacts, and demographics. Altogether, 15 individual z scores are computed, by dividing the difference between predicted (Xp) and obtained (Xo) follow-up scaled scores by the error term of the regression model (Xo-Xp/SD-residual) and then averaged to generate the sRCS. Scores center around 0 (no change), with negative scores indicating decline and positive scores improvement. Significant changes are defined by 90% confidence intervals (±1.645 SD) such that participants in the top 5% of the sRCS distribution of the normative, stable reference sample were defined as "improved," and the bottom 5% were defined the "decliners."

Secondary outcomes(1)
  1. Insulin-like Growth Factor 1 (IGF-1)

    Time frame · Baseline and week 24

    Registry description

    Change in Insulin-like growth factor 1 (IGF-1), a biomarker of visceral adipose tissue (VAT)-related inflammation and immune activation, from baseline to week 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and week 24

Change in Neurocognitive Performance

GroupValue (Z-score)
Immediate Group0.146
Deferred Group0.103
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline and week 24

Insulin-like Growth Factor 1 (IGF-1)

GroupValue (% increase in IGF-1 from week 0 to 24)
Immediate Group53.2
Deferred Group5.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Immediate Group1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV0 / 432 / 4337 / 43
Deferred GroupNo treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV0 / 300 / 3020 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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