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

NCT02572323 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: R01AG048650
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Neurocognitive Performance

  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."

  Baseline and week 24

Secondary Outcomes (1)

• Insulin-like Growth Factor 1 (IGF-1)

  Baseline and week 24

Study Arms (2)

Immediate group

ACTIVE COMPARATOR

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

Drug: Tesamorelin

Deferred group

PLACEBO COMPARATOR

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

Drug: Tesamorelin

Interventions

Tesamorelin DRUG

Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV

Also known as: Egrifta

Deferred group; Immediate group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Southern California: collaborator
• PalmTree Clinical Research Inc.: collaborator
• University of California, San Francisco: collaborator

Study Sites (4)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

PalmTree

Palm Springs, California, 92262, United States

Location

HIV Neurobehavioral Research Program (HNRP)

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ronald Ellis
• Organization: UC San Diego

roellis@health.ucsd.edu

619-787-4587

Study Officials

• Ronald J Ellis, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Fred Sattler, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosciences

Model Details: Participants are randomly assigned to the immediate or deferred group. Participants in the Immediate group receive tesamorelin for 6 months and then no drug for 6 months. Participants in the Deferred group receive no drug for 6 months and then tesamorelin for 6 months.

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 8, 2015
• Study Start: February 15, 2017
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)