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

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