Expired Study
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Philadelphia, Pennsylvania 19102


Purpose:

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


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


NCT ID:

NCT00637572


Primary Contact:

Principal Investigator
Jan Fourie, MD
58 Ann Street, Dundee, KZ-Natal 3000, S. Africa


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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