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

This study has been completed.
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00637572
First received: March 11, 2008
Last updated: September 14, 2016
Last verified: August 2016

March 11, 2008
September 14, 2016
December 2004
June 2005   (final data collection date for primary outcome measure)
Change in Body Weight [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Weight gain [ Time Frame: Baseline, then weekly for 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00637572 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Lean Mass [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Impedance [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Hip Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Waist Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Tricep Skinfold [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Mid-arm Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Total Energy [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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").
  • Bioimpedance analysis [ Time Frame: Baseline, weeks 6 and 12 ] [ Designated as safety issue: No ]
  • Appetite and food intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12 weeks plus 30 days after study drug stopped ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
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)
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Cachexia
  • Anorexia
  • AIDS Wasting Syndrome
  • HIV Wasting Syndrome
  • 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)
    Other Name: Megace ES
  • 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)
    Other Name: Megace
  • Experimental: Megestrol acetate oral suspension nanocrystal dispersion
    Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL
    Intervention: Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
  • Active Comparator: Megestrol acetate oral suspension micronized formulation
    Megestrol acetate oral suspension micronized formulation 60 mg/mL
    Intervention: Drug: Megestrol acetate oral suspension 40 mg/mL
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Capable of and willing to provide informed consent
  • Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator)
  • An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weight for frame size, or a recent history of unintentional weight loss of 10% from the subjects baseline
  • Weight losses was clinically associated with AIDS-related wasting and not related to any other disease process
  • Women of childbearing potential had to agree to use effective contraception for the duration of the study and for two weeks after the last dose
  • Clinical laboratory values had to be within normal limits or out-of-range limits must be designated as not clinically significant (some exceptions per protocol)
  • Able to read and write in the study related documents translated into the primary local language
  • Capable of and willing to return to the clinic regularly for study visits
  • Must have been taking a stable regimen of accepted HIV anti-retroviral treatments for at least two weeks prior to study entry
  • Capable of completing a 3-day food intake diary with instruction
  • Willing to abstain from any illegal or recreational drug substances for the duration of the trial
  • Willing to abstain from taking any other medications or substances known to affect appetite or weight gain (eg, steroids [other than those inhaled for treatment of asthmatic conditions], nutritional supplements [other than vitamins or minerals], dronabinol, recombinant human growth hormone, etc.)

Exclusion Criteria:

  • Weight loss due to factors other than AIDS-related wasting
  • Enrollment in any other clinical trial
  • Lack of access to regular meals
  • Women of childbearing potential could not be pregnant or nursing
  • Clinically severe depression evidenced by a baseline score of 17 or more on the Hamilton Depression Rating Scale (GRID-HAMD-17)
  • Recent evidence of or history of significant psychiatric illness that may have compromised the subject's ability to comply with the study requirements
  • Intractable or frequent vomiting that regularly interfered with eating
  • Clinically significant diarrhea that would have interfered with absorption of foods or medications
  • Clinically significant oral lesions or dental conditions that would have interfered with eating a regular diet
  • History or evidence of thromboembolic events or any first degree relative with a history of thromboembolic events
  • Active AIDS-defining illness or other clinically significant or uncontrolled medical problems
  • Current evidence of or history of diabetes mellitus or hypoadrenalism
  • Systemic treatment with glucocorticoids within the 12 months prior to study entry
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   South Africa
 
NCT00637572
PAR-002
No
No
Not Provided
Endo Pharmaceuticals
Endo Pharmaceuticals
Quintiles, Inc.
Principal Investigator: Jan Fourie, MD 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
Endo Pharmaceuticals
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP