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Tesamorelin

Egrifta, TH9507

Quick Stats
Studies 64
Trials 24
Completed PHASE2 INTERVENTIONAL NCT02572323

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

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.

Interventions

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

Primary Outcomes

Measure: Neurocognitive performance
TimeFrame: 6 months and 12 months
Description: Change in neurocognitive performance measured by Global Deficit Score (GDS)

Trial Information

NCT ID

NCT02572323

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

University of California, San Diego

Last Updated

December 15, 2025