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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637572
• Other study ID #: PAR-002
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: September 7, 2017
• Start date: December 2004
• Est. completion date: June 2005

Study information

• Verified date: September 2017
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS Wasting Syndrome
• Anorexia
• Cachexia
• HIV Infections
• HIV Wasting Syndrome
• Syndrome
• Weight Gain

Intervention

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)
• Megestrol acetate oral suspension 40 mg/mL
Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	Quintiles, Inc.

Countries where clinical trial is conducted

United States,  India,  South Africa, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	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	Change From Baseline in Lean Mass		Baseline (Day 1) to Week 12
Secondary	Change From Baseline in Impedance	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
Secondary	Change From Baseline in Body Fat Mass		Baseline (Day 1) to Week 12
Secondary	Change in Hip Circumference		Baseline (Day 1) to Week 12
Secondary	Change in Waist Circumference		Baseline (Day 1) to Week 12
Secondary	Change in Tricep Skinfold		Baseline (Day 1) to Week 12
Secondary	Change in Mid-arm Circumference		Baseline (Day 1) to Week 12
Secondary	Change in Total Energy	Food intake was quantified by the 24-hour recall food diary	Baseline (Day 1) to Week 12
Secondary	Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)	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
Secondary	Appetite at Baseline (Day 3) and 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

External Links

•   Link to published study