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

Completed · Phase 2

Conditions studied: HIV Infections, Cachexia, Anorexia, AIDS Wasting Syndrome, HIV Wasting Syndrome

In brief

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

Key facts

Study ID

NCT00637572

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

63

Starts

2004-12-01

Expected to finish

2005-06-01

Last updated by the study team

2017-10-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Victoria Hospital — Bangalore, Karnataka, India
• M.S. Ramaiah Medical College and Hospital — Bangalore, Karnataka, India
• Kasturba Medical College — Mangalore, Karnataka, India
• Ruby Hall Clinic and Grant Medical Foundation — Pune, Maharashtra, India
• St Mary's Hospital — Private Bag, Ashwood, South Africa
• Quinta-research — Pellissier, Bloemfontein, South Africa
• Genclin Corporation, Clinical Trial Centre — Westdene, Bloemfontein, South Africa
• 40 Arthur Hobbs Street — Boksburg, Johannesburg, South Africa
• 6 Calypso Centre — Richards Bay, KwaZulu-Natal, South Africa
• Eastmed Hospital — Eastlynn, Pretoria, South Africa
• TrialTech Clinical Research — Hatfield, Pretoria, South Africa

Full record on ClinicalTrials.gov

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