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

What Was Tested

The trial (phase 2) is built around Tesamorelin.

It had two arms (groups): Immediate group (active comparator) and Deferred group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Before entry, volunteers will be required to show evidence of abdominal obesity and a minimum level of memory and thinking difficulties on cognitive tests.

Who Took Part

The registry lists 73 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 16 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Tesamorelin and who got the comparison, which limits bias.

Each person switched between Tesamorelin and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Tesamorelin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-02-15 with completion listed for 2023-10-15.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Neurocognitive Performance (time frame: Baseline and week 24).

It also tracked 1 secondary outcome, for example Insulin-like Growth Factor 1 (IGF-1).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 73 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, all human trials.