Status:
COMPLETED
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Lead Sponsor:
Endo Pharmaceuticals
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
HIV Infections
Cachexia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 suspens...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00637572
Start Date
December 1 2004
End Date
June 1 2005
Last Update
October 5 2017
Active Locations (12)
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1
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
2
Victoria Hospital
Bangalore, Karnataka, India, 560002
3
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India, 560054
4
Kasturba Medical College
Mangalore, Karnataka, India, 575003