Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Condition: HIV Infections; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome
MeSH terms: HIV Wasting Syndrome; Wasting Syndrome; Syndrome; Anorexia; Weight Gain; Cachexia
Intervention: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL; Megestrol acetate oral suspension 40 mg/mL
Intervention description: 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)
Intervention MeSH terms: Megestrol; Megestrol Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Weight loss; Cachexia; Anorexia; Megestrol acetate oral suspension; Nanocrystal dispersion; Nanocrystal technology; Body weight changes; AIDS wasting; HIV wasting; Emaciation; Megace ES; Megace; Treatment Experienced

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
    

Eligibility criteria:

        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