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
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637572
First received: March 11, 2008
Last updated: April 1, 2008
Last verified: March 2008

March 11, 2008
April 1, 2008
December 2004
June 2005   (final data collection date for primary outcome measure)
Weight gain [ Time Frame: Baseline, then weekly for 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00637572 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
  • Unintended Weight Loss
  • 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: 1
    Megestrol acetate oral suspension nanocrystal dispersion formulation
    Intervention: Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
  • Active Comparator: 2
    Megestrol acetate oral suspension micronized formulation
    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
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   South Africa
 
NCT00637572
PAR-002
No
VP Clinical and Medical Affairs, Par Pharmaceutical, Inc
Par Pharmaceutical, Inc.
Quintiles
Principal Investigator: Jan Fourie, MD 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
Par Pharmaceutical, Inc.
March 2008

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