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

September 7, 2017 updated by: Endo Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital
      • Bangalore, Karnataka, India, 560054
        • M.S. Ramaiah Medical College and Hospital
      • Mangalore, Karnataka, India, 575003
        • Kasturba Medical College
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic and Grant Medical Foundation
  • South Africa
    • Ashwood
      • Private Bag, Ashwood, South Africa, 3605
        • St Mary's Hospital
    • Bloemfontein
      • Pellissier, Bloemfontein, South Africa, 9317
        • Quinta-research
      • Westdene, Bloemfontein, South Africa, 9301
        • Genclin Corporation, Clinical Trial Centre
    • Johannesburg
      • Boksburg, Johannesburg, South Africa, 1466
        • 40 Arthur Hobbs Street
    • Kwazulu Natal
      • Richards Bay, Kwazulu Natal, South Africa, 3900
        • 6 Calypso Centre
    • Pretoria
      • Eastlynn, Pretoria, South Africa, 0186
        • Eastmed Hospital
      • Hatfield, Pretoria, South Africa, 0001
        • TrialTech Clinical Research
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Megace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (Day 1) to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Lean Mass
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
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.
Baseline (Day 1) to Week 12
Change From Baseline in Body Fat Mass
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
Change in Hip Circumference
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
Change in Waist Circumference
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
Change in Tricep Skinfold
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
Change in Mid-arm Circumference
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12
Change in Total Energy
Time Frame: Baseline (Day 1) to Week 12
Food intake was quantified by the 24-hour recall food diary
Baseline (Day 1) to Week 12
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.
Baseline (Day 3) to Week 12
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").
Baseline (Day 3) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Collaborators

Quintiles, Inc.

Investigators

  • Principal Investigator: Jan Fourie, MD, 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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