Conditions: HIV Infections Cachexia Anorexia AIDS Wasting Syndrome HIV Wasting Syndrome
Keywords: Weight loss Cachexia Anorexia Megestrol acetate oral suspension Nanocrystal dispersion Nanocrystal technology Body weight changes AIDS wasting HIV wasting Emaciation Megace ES Megace Treatment Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL arm 2: Megestrol acetate oral suspension micronized formulation 60 mg/mL

Interventions: intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL intervention 2: Megestrol acetate oral suspension 40 mg/mL
Intervention descriptions: intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) intervention 2: Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)

Protocol document: