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

March 4, 2026 updated by: Ronald Ellis, University of California, San Diego
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

HIV infection can result in memory and thinking difficulties in some people, even those successfully treated with antiretroviral medications. Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV. Abdominal fat accumulation is linked to memory and thinking difficulties, and previous studies have suggested that tesamorelin also may be beneficial for memory and thinking, but this has not been tested in HIV. 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. We plan to enroll 100 volunteers with HIV infection at 2 sites - the University of California, San Diego and the University of Southern California, University of San Francisco and the satellite site, PalmTree Clinical Research, Inc. Before entry, volunteers will be required to show evidence of abdominal obesity and a minimum level of memory and thinking difficulties on cognitive tests. This is a randomized trial in which each volunteer will have a 60% chance of initially receiving tesamorelin (the immediate group) and a 40% chance of initially receiving no treatment (the deferred group). Subsequently, the deferred group (those who initially received no treatment) will receive tesamorelin for 6 months and those who initially received tesamorelin will receive no treatment for 6 months. Volunteers will be trained in the use of a 2-way text-messaging system that will help the research team to support volunteers' ability to take the study medication as directed. We will measure volunteers' memory and thinking skills before and at the end of treatment. We will collect blood at various points during the study to check for safety of the treatment and to determine its effects on the body. Volunteers will also be asked to have magnetic resonance scans of the head and abdomen to monitor the effects of the study medication on brain chemistry and abdominal fat.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of the University of Southern California
      • Palm Springs, California, United States, 92262
        • PalmTree
      • San Diego, California, United States, 92103
        • HIV Neurobehavioral Research Program (HNRP)
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immediate group
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Drug: Tesamorelin
Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
Other Names:
  • Egrifta
Placebo Comparator: Deferred group
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Drug: Tesamorelin
Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
Other Names:
  • Egrifta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Neurocognitive Performance
Time Frame: Baseline and week 24
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin-like Growth Factor 1 (IGF-1)
Time Frame: Baseline and week 24
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
Baseline and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern California
University of California, San Francisco
PalmTree Clinical Research Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronald J Ellis, MD, PhD, University of California, San Diego
  • Principal Investigator: Fred Sattler, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AG048650 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings