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

This study has been completed.
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00637572
First received: March 11, 2008
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
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

Condition Intervention Phase
HIV Infections
Cachexia
Anorexia
AIDS Wasting Syndrome
HIV Wasting Syndrome
Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment


Secondary Outcome Measures:
  • Change From Baseline in Lean Mass [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Impedance [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.

  • Change From Baseline in Body Fat Mass [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Hip Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Waist Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Tricep Skinfold [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Mid-arm Circumference [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Change in Total Energy [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    Food intake was quantified by the 24-hour recall food diary

  • Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI) [ Time Frame: Baseline (Day 3) to Week 12 ] [ Designated as safety issue: No ]
    The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.

  • Appetite at Baseline (Day 3) and Week 12 [ Time Frame: Baseline (Day 3) to Week 12 ] [ Designated as safety issue: No ]
    Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").


Enrollment: 63
Study Start Date: December 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megestrol acetate oral suspension nanocrystal dispersion
Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL
Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
Other Name: Megace ES
Active Comparator: Megestrol acetate oral suspension micronized formulation
Megestrol acetate oral suspension micronized formulation 60 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL
Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
Other Name: Megace

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637572

Locations
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
India
Victoria Hospital
Bangalore, Karnataka, India, 560002
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India, 560054
Kasturba Medical College
Mangalore, Karnataka, India, 575003
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India, 411001
South Africa
St Mary's Hospital
Private Bag, Ashwood, South Africa, 3605
Quinta-research
Pellissier, Bloemfontein, South Africa, 9317
Genclin Corporation, Clinical Trial Centre
Westdene, Bloemfontein, South Africa, 9301
40 Arthur Hobbs Street
Boksburg, Johannesburg, South Africa, 1466
6 Calypso Centre
Richards Bay, Kwazulu Natal, South Africa, 3900
Eastmed Hospital
Eastlynn, Pretoria, South Africa, 0186
TrialTech Clinical Research
Hatfield, Pretoria, South Africa, 0001
Sponsors and Collaborators
Endo Pharmaceuticals
Quintiles, Inc.
Investigators
Principal Investigator: Jan Fourie, MD 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
  More Information

Additional Information:
Publications:
Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00637572     History of Changes
Other Study ID Numbers: PAR-002 
Study First Received: March 11, 2008
Results First Received: January 29, 2016
Last Updated: March 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Weight loss
Cachexia
Anorexia
Megestrol acetate oral suspension
Nanocrystal dispersion
Nanocrystal technology
Body weight changes
AIDS wasting
HIV wasting
Emaciation
Megace ES
Megace
Treatment Experienced

Additional relevant MeSH terms:
Anorexia
Cachexia
HIV Wasting Syndrome
Syndrome
Wasting Syndrome
Weight Gain
Body Weight
Body Weight Changes
Disease
Emaciation
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Nutrition Disorders
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Signs and Symptoms, Digestive
Virus Diseases
Weight Loss
Megestrol
Megestrol Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Appetite Stimulants

ClinicalTrials.gov processed this record on May 24, 2016