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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Or

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 Summary:
Sponsor: Endo Pharmaceuticals

Current Primary Outcome: Change in Body Weight [ Time Frame: Baseline (Day 1) to Week 12 ]

Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment


Original Primary Outcome: Weight gain [ Time Frame: Baseline, then weekly for 12 weeks ]

Current Secondary Outcome:

  • Change From Baseline in Lean Mass [ Time Frame: Baseline (Day 1) to Week 12 ]
  • Change From Baseline in Impedance [ Time Frame: Baseline (Day 1) to Week 12 ]
    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.
  • 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 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Food intake was quantified by the 24-hour recall food diary
  • Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI) [ Time Frame: Baseline (Day 3) to Week 12 ]
    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.
  • Appetite at Baseline (Day 3) and Week 12 [ Time Frame: Baseline (Day 3) to 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").


Original Secondary Outcome:

  • Bioimpedance analysis [ Time Frame: Baseline, weeks 6 and 12 ]
  • Appetite and food intake [ Time Frame: 12 weeks ]
  • Quality of Life [ Time Frame: 12 weeks plus 30 days after study drug stopped ]


Information By: Endo Pharmaceuticals

Dates:
Date Received: March 11, 2008
Date Started: December 2004
Date Completion:
Last Updated: September 14, 2016
Last Verified: August 2016