evaluate weight gain using 2 different formulations of megestrol acetate oral suspension for aids-related weight loss

Conditions: HIV Infections; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome

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

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