TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

What Was Tested

The trial (phase 3) is built around Tesamorelin.

It had three arms (groups): Tesamorelin 12 months (T-T) (experimental), Tesamorelin-Placebo (T-P) (experimental) and Placebo-Tesamorelin (P-T) (experimental).

The registry classes the interventions as drug.

More on the Plan

The present study is aimed at confirming the observations made during the first Phase 3 study.

Who Took Part

Enrollment: 263 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: Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study. Signed informed consent before any trial-related activities.

The full record lists 2 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Neither the participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-08 with completion listed for 2008-10.

It ran at 47 sites in United States (27), Canada (7), United Kingdom (5), France (4), Spain (3) and Belgium (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes From Baseline in Fasting Blood Glucose at Week 52 (time frame: Baseline and Week 52). Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 (time frame: Baseline and Week 52).

It also tracked 1 secondary outcome, for example Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tesamorelin in 263 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.