NCT01591902

Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate Whether EGRIFTA® (Tesamorelin for Injection), 2 mg Once Daily SC, Increases the Risk of Development or Progression of Diabetic Retinopathy When Administered to HIV-infected Subjects With Abdominal Lipohypertrophy and Concomitant Diabetes

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Theratechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).

Detailed description

To date, EGRIFTA® has not been studied for longer than 1 year in human subjects, nor has EGRIFTA® been studied in Type 2 diabetic HIV-infected subjects who are receiving oral hypoglycemic agents, GLP-1 analogues, or insulin. The present study will assess the potential of EGRIFTA® to induce or exacerbate DR in HIV-infected subjects on antiretroviral therapy who have concomitant abdominal lipohypertrophy and T2DM, and explore the long-term effects of EGRIFTA® on glycemic control and major adverse cardiovascular event (MACE) in this population.

Conditions

• Diabetic Retinopathy
• HIV

Interventions

Type	Name	Description
DRUG	Tesamorelin	Daily 2 mg subcutaneous injections of tesamorelin
DRUG	Placebo-Control	3.0 mL vials

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-05-01
• Completion: 2018-08-01
• First posted: 2012-05-04
• Last updated: 2018-09-11

Locations

24 sites across 1 country: United States