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)
Sponsor study identifier
interventional
63
3 countries
12
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2005
Actual (reported)Study Completion
June 2005
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
June 2005
Actual (reported)June 2005
Actual (reported)March 11, 2008
Actual (reported)March 18, 2008
Actual (reported)April 20, 2016
Actual (reported)Change in Body Weight
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Baseline (Day 1) to Week 12
Change From Baseline in Lean Mass
Baseline (Day 1) to Week 12
Change From Baseline in Impedance
Baseline (Day 1) to Week 12
Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL
Megestrol acetate oral suspension micronized formulation 60 mg/mL
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Victoria Hospital
Bangalore, Karnataka, 560002, India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054, India
Kasturba Medical College
Mangalore, Karnataka, 575003, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001, India
St Mary's Hospital
Private Bag, Ashwood, 3605, South Africa
Quinta-research
Pellissier, Bloemfontein, 9317, South Africa
Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216
Jan Fourie, MD
58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
63 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2008
First Posted
March 18, 2008
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Change From Baseline in Body Fat Mass
Baseline (Day 1) to Week 12
Change in Hip Circumference
Baseline (Day 1) to Week 12
Change in Waist Circumference
Baseline (Day 1) to Week 12
Contact the study team to confirm eligibility.
Genclin Corporation, Clinical Trial Centre
Westdene, Bloemfontein, 9301, South Africa
40 Arthur Hobbs Street
Boksburg, Johannesburg, 1466, South Africa
6 Calypso Centre
Richards Bay, KwaZulu-Natal, 3900, South Africa
Eastmed Hospital
Eastlynn, Pretoria, 0186, South Africa
TrialTech Clinical Research
Hatfield, Pretoria, 0001, South Africa
Primary Completion
June 2005
Actual (reported)Study Completion
June 2005
Actual (reported)Last Updated
October 5, 2017
Results First Posted
April 20, 2016
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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