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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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, United States
Victoria Hospital
Bangalore, Karnataka, India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India
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
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Lean Mass
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Impedance
Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Body Fat Mass
Time frame: Baseline (Day 1) to Week 12
Change in Hip Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Waist Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Tricep Skinfold
Time frame: Baseline (Day 1) to Week 12
Change in Mid-arm Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Total Energy
Food intake was quantified by the 24-hour recall food diary
Time frame: Baseline (Day 1) to Week 12
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Kasturba Medical College
Mangalore, Karnataka, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India
St Mary's Hospital
Private Bag, Ashwood, South Africa
Quinta-research
Pellissier, Bloemfontein, South Africa
Genclin Corporation, Clinical Trial Centre
Westdene, Bloemfontein, South Africa
40 Arthur Hobbs Street
Boksburg, Johannesburg, South Africa
6 Calypso Centre
Richards Bay, KwaZulu-Natal, South Africa
...and 2 more locations
Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 \[worse to better\]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.
Time frame: Baseline (Day 3) to Week 12
Appetite at Baseline (Day 3) and Week 12
Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").
Time frame: Baseline (Day 3) to Week 12