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

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