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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637572
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 20, 2016
Last Update Posted : October 5, 2017
Quintiles, Inc.
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Baseline (Day 1) to Week 12 ]
    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 :
  1. Change From Baseline in Lean Mass [ Time Frame: Baseline (Day 1) to Week 12 ]
  2. Change From Baseline in Impedance [ Time Frame: Baseline (Day 1) to Week 12 ]
    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.

  3. Change From Baseline in Body Fat Mass [ Time Frame: Baseline (Day 1) to Week 12 ]
  4. Change in Hip Circumference [ Time Frame: Baseline (Day 1) to Week 12 ]
  5. Change in Waist Circumference [ Time Frame: Baseline (Day 1) to Week 12 ]
  6. Change in Tricep Skinfold [ Time Frame: Baseline (Day 1) to Week 12 ]
  7. Change in Mid-arm Circumference [ Time Frame: Baseline (Day 1) to Week 12 ]
  8. Change in Total Energy [ Time Frame: Baseline (Day 1) to Week 12 ]
    Food intake was quantified by the 24-hour recall food diary

  9. 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 ]
    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.

  10. Appetite at Baseline (Day 3) and Week 12 [ Time Frame: Baseline (Day 3) to Week 12 ]
    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").

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637572

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United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
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
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.
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Principal Investigator: Jan Fourie, MD 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
Additional Information:
Publications of Results:
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

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Responsible Party: Endo Pharmaceuticals Identifier: NCT00637572    
Other Study ID Numbers: PAR-002
First Posted: March 18, 2008    Key Record Dates
Results First Posted: April 20, 2016
Last Update Posted: October 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Endo Pharmaceuticals:
Weight loss
Megestrol acetate oral suspension
Nanocrystal dispersion
Nanocrystal technology
Body weight changes
AIDS wasting
HIV wasting
Megace ES
Treatment Experienced
Additional relevant MeSH terms:
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HIV Wasting Syndrome
Wasting Syndrome
Weight Gain
Pathologic Processes
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms, Digestive
Metabolic Diseases
Nutrition Disorders
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents