NCT00637572

Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss

A Randomized, Open-labeled, Pilot Study Comparing Weight Gain in Adults With AIDS-related Wasting Given Either Megestrol Acetate Oral Suspension Nanocrystal Dispersion (MA-NCD) or Megestrol Acetate Oral Suspension (Megace)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

Conditions

• HIV Infections
• Cachexia
• Anorexia
• AIDS Wasting Syndrome
• HIV Wasting Syndrome

Interventions

Type	Name	Description
DRUG	Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL	Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
DRUG	Megestrol acetate oral suspension 40 mg/mL	Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2008-03-18
• Last updated: 2017-10-05
• Results posted: 2016-04-20

Locations

12 sites across 3 countries: United States, India, South Africa