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

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2005

Conditions
HIV InfectionsCachexiaAnorexiaAIDS Wasting SyndromeHIV Wasting Syndrome
Interventions
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)

Trial Locations (12)

1466

40 Arthur Hobbs Street, Boksburg

3605

St Mary's Hospital, Private Bag

3900

6 Calypso Centre, Richards Bay

9301

Genclin Corporation, Clinical Trial Centre, Westdene

9317

Quinta-research, Pellissier

19102

Drexel University College of Medicine, Philadelphia

411001

Ruby Hall Clinic and Grant Medical Foundation, Pune

560002

Victoria Hospital, Bangalore

560054

M.S. Ramaiah Medical College and Hospital, Bangalore

575003

Kasturba Medical College, Mangalore

0186

Eastmed Hospital, Eastlynn

0001

TrialTech Clinical Research, Hatfield

Sponsors
All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Endo Pharmaceuticals

INDUSTRY