TH9507 in Patients With HIV-Associated Lipodystrophy

What Was Tested

This registered phase 3 trial tested Tesamorelin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 412 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Ages 18 to 65 years inclusive. HIV positive; CD4 cell counts \>100 cells/mm3; viral load \<10,000 copies/mL (stable for 8 weeks). On stable ART regimen for at least 8 weeks prior to randomization. Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:. For males: waist circumference \> 95 cm and waist to hip ratio \> 0.94;.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: body mass index \< 20 kg/m2; opportunistic infection; hiv-related disease within 3 months of study; history of malignancy; active neoplasm.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Tesamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tesamorelin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tesamorelin.

It started in 2005-06 with completion listed for 2006-11.

It ran at 42 sites in United States (35) and Canada (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Visceral adipose tissue (VAT).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tesamorelin in 412 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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