Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Involuntary Weight Loss; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome
Intervention: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL (Drug); Megestrol acetate oral suspension 40 mg/mL (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Par Pharmaceutical, Inc. Official(s) and/or principal investigator(s): Jan Fourie, MD, Principal Investigator, Affiliation: 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
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
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Weight gain
Secondary outcome: Bioimpedance analysisAppetite and food intake Quality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
St Mary's Hospital, Private Bag, Ashwood 3605, South Africa
Quinta-research, Pellissier, Bloemfontein 9317, South Africa
Genclin Corporation, Clinical Trial Centre, Westdene, Bloemfontein 9301, South Africa
40 Arthur Hobbs Street, Boksburg, Johannesburg 1466, South Africa
M.S. Ramaiah Medical College and Hospital, Bangalore, Karnataka 560054, India
Victoria Hospital, Bangalore, Karnataka 560002, India
Kasturba Medical College, Mangalore, Karnataka 575003, India
6 Calypso Centre, Richards Bay, Kwazulu Natal 3900, South Africa
Ruby Hall Clinic and Grant Medical Foundation, Pune, Maharashtra 411001, India
Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States
Eastmed Hospital, Eastlynn, Pretoria 0186, South Africa
TrialTech Clinical Research, Hatfield, Pretoria 0001, South Africa
Additional Information
Link to published study
Starting date: December 2004
Last updated: August 17, 2015
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