Clinical trial NCT00637572: Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Cachexia
Anorexia
AIDS Wasting Syndrome
HIV Wasting Syndrome
Keywords: 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
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2008-03-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline (Day 1) to Week 12
Secondary outcomes:
measure: Change From Baseline in Lean Mass
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Impedance
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Body Fat Mass
timeFrame: Baseline (Day 1) to Week 12
measure: Change in Hip Circumference
timeFrame: Baseline (Day 1) to Week 12
measure: Change in Waist Circumference
timeFrame: Baseline (Day 1) to Week 12
measure: Change in Tricep Skinfold
timeFrame: Baseline (Day 1) to Week 12
measure: Change in Mid-arm Circumference
timeFrame: Baseline (Day 1) to Week 12
measure: Change in Total Energy
timeFrame: Baseline (Day 1) to Week 12
measure: Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
timeFrame: Baseline (Day 3) to Week 12
measure: Appetite at Baseline (Day 3) and Week 12
timeFrame: Baseline (Day 3) to Week 12
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Bangalore
country: India
facility: Victoria Hospital
state: Karnataka
city: Bangalore
country: India
facility: M.S. Ramaiah Medical College and Hospital
state: Karnataka
city: Mangalore
country: India
facility: Kasturba Medical College
state: Karnataka
city: Pune
country: India
facility: Ruby Hall Clinic and Grant Medical Foundation
state: Maharashtra
city: Private Bag
country: South Africa
facility: St Mary's Hospital
state: Ashwood
city: Pellissier
country: South Africa
facility: Quinta-research
state: Bloemfontein
city: Westdene
country: South Africa
facility: Genclin Corporation, Clinical Trial Centre
state: Bloemfontein
city: Boksburg
country: South Africa
facility: 40 Arthur Hobbs Street
state: Johannesburg
city: Richards Bay
country: South Africa
facility: 6 Calypso Centre
state: Kwazulu Natal
city: Eastlynn
country: South Africa
facility: Eastmed Hospital
state: Pretoria
city: Hatfield
country: South Africa
facility: TrialTech Clinical Research
state: Pretoria
Study officials:
affiliation: 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
name: Jan Fourie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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