Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS… (NCT00637572) | Clinical Trial Compass
CompletedPhase 2
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
United States, India63 participantsStarted 2004-12
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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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 supp…