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

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