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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborator: Quintiles, Inc.
• Treatments: Megestrol; Megestrol Acetate

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