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

Phase 2

Completed

Conditions: Anorexia
HIV Wasting Syndrome
AIDS Wasting Syndrome
HIV Infections
Cachexia

Interventions: Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL

Registration Number: NCT00637572

Lead Sponsor: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Megestrol acetate oral suspension nanocrystal dispersion	Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL	Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL
Megestrol acetate oral suspension micronized formulation	Megestrol acetate oral suspension 40 mg/mL	Megestrol acetate oral suspension micronized formulation 60 mg/mL

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	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

Name	Time	Method
Change From Baseline in Lean Mass	Baseline (Day 1) to Week 12
Change in Mid-arm Circumference	Baseline (Day 1) to Week 12
Change in Total Energy	Baseline (Day 1) to Week 12	Food intake was quantified by the 24-hour recall food diary
Change From Baseline in Impedance	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.
Change From Baseline in Body Fat Mass	Baseline (Day 1) to Week 12
Change in Hip Circumference	Baseline (Day 1) to Week 12
Change in Waist Circumference	Baseline (Day 1) to Week 12
Change in Tricep Skinfold	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)	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.
Appetite at Baseline (Day 3) and Week 12	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").

Trial Locations

Locations (12): M.S. Ramaiah Medical College and Hospital
🇮🇳
Bangalore, Karnataka, India
St Mary's Hospital
🇿🇦
Private Bag, Ashwood, South Africa
Quinta-research
🇿🇦
Pellissier, Bloemfontein, South Africa
Drexel University College of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Victoria Hospital
🇮🇳
Bangalore, Karnataka, India
Ruby Hall Clinic and Grant Medical Foundation
🇮🇳
Pune, Maharashtra, India
40 Arthur Hobbs Street
🇿🇦
Boksburg, Johannesburg, South Africa
6 Calypso Centre
🇿🇦
Richards Bay, Kwazulu Natal, South Africa
Eastmed Hospital
🇿🇦
Eastlynn, Pretoria, South Africa
TrialTech Clinical Research
🇿🇦
Hatfield, Pretoria, South Africa
Genclin Corporation, Clinical Trial Centre
🇿🇦
Westdene, Bloemfontein, South Africa
Kasturba Medical College
🇮🇳
Mangalore, Karnataka, India