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Clinical Trial Name -Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-Related Weight Loss
| Original Study ID : PAR-002 |
| NCT ID : NCT00637572 |
| Brief Title : Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-Related Weight Loss |
| Official Title : A Randomized, Open-Labeled, Pilot Study Comparing Weight Gain in Adults With AIDS-Related Wasting Given Either Megestrol Acetate Oral Suspension Nanocrystal Dispersion (MA-NCD) or Megestrol Acetate Oral Suspension (Megace) |
| Brief 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 |
| Source : Par Pharmaceutical, Inc. |
| Overall Status : Completed |
| Start Date : December 2004 |
| End Date : June 2005 |
| Completion Date : June 2005 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Enrollment : 63 |
| Verification Date : March 2008 |
| First Received Date : March 11, 2008 |
| Trial Eligibility |
| 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 70 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Drexel University College of Medicine |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19102 |
| Country : United States |
| Facility Name : M.S. Ramaiah Medical College and Hospital |
| City : Bangalore |
| State : Karnataka |
| Zip Code : 560054 |
| Country : India |
| Facility Name : Kasturba Medical College |
| City : Mangalore |
| State : Karnataka |
| Zip Code : 575003 |
| Country : India |
| Facility Name : Victoria Hospital |
| City : Bangalore |
| State : Karnataka |
| Zip Code : 560002 |
| Country : India |
| Facility Name : Ruby Hall Clinic and Grant Medical Foundation |
| City : Pune |
| State : Maharashtra |
| Zip Code : 411001 |
| Country : India |
| Facility Name : St Mary's Hospital |
| City : Private Bag |
| State : Ashwood |
| Zip Code : 3605 |
| Country : South Africa |
| Facility Name : Genclin Corporation, Clinical Trial Centre |
| City : Westdene |
| State : Bloemfontein |
| Zip Code : 9301 |
| Country : South Africa |
| Facility Name : Quinta-research |
| City : Pellissier |
| State : Bloemfontein |
| Zip Code : 9317 |
| Country : South Africa |
| Facility Name : 40 Arthur Hobbs Street |
| City : Boksburg |
| State : Johannesburg |
| Zip Code : 1466 |
| Country : South Africa |
| Facility Name : 6 Calypso Centre |
| City : Richards Bay |
| State : Kwazulu Natal |
| Zip Code : 3900 |
| Country : South Africa |
| Facility Name : TrialTech Clinical Research |
| City : Hatfield |
| State : Pretoria |
| Zip Code : 0001 |
| Country : South Africa |
| Facility Name : Eastmed Hospital |
| City : Eastlynn |
| State : Pretoria |
| Zip Code : 0186 |
| Country : South Africa |
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