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

Original Study ID : PAR-002

NCT ID : NCT00637572

Brief Title : 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)

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

Source : Par Pharmaceutical, Inc.

Overall Status : Completed

Start Date : December 2004

End Date : June 2005

Completion Date : June 2005

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Enrollment : 63

Verification Date : March 2008

First Received Date : March 11, 2008

Trial 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : 70 Years

Healthy Volunteers : No

Facilities

Facility Name : Drexel University College of Medicine

City : Philadelphia

State : Pennsylvania

Zip Code : 19102

Country : United States

Facility Name : M.S. Ramaiah Medical College and Hospital

City : Bangalore

State : Karnataka

Zip Code : 560054

Country : India

Facility Name : Kasturba Medical College

City : Mangalore

State : Karnataka

Zip Code : 575003

Country : India

Facility Name : Victoria Hospital

City : Bangalore

State : Karnataka

Zip Code : 560002

Country : India

Facility Name : Ruby Hall Clinic and Grant Medical Foundation

City : Pune

State : Maharashtra

Zip Code : 411001

Country : India

Facility Name : St Mary's Hospital

City : Private Bag

State : Ashwood

Zip Code : 3605

Country : South Africa

Facility Name : Genclin Corporation, Clinical Trial Centre

City : Westdene

State : Bloemfontein

Zip Code : 9301

Country : South Africa

Facility Name : Quinta-research

City : Pellissier

State : Bloemfontein

Zip Code : 9317

Country : South Africa

Facility Name : 40 Arthur Hobbs Street

City : Boksburg

State : Johannesburg

Zip Code : 1466

Country : South Africa

Facility Name : 6 Calypso Centre

City : Richards Bay

State : Kwazulu Natal

Zip Code : 3900

Country : South Africa

Facility Name : TrialTech Clinical Research

City : Hatfield

State : Pretoria

Zip Code : 0001

Country : South Africa

Facility Name : Eastmed Hospital

City : Eastlynn

State : Pretoria

Zip Code : 0186

Country : South Africa

OutComes

Primary OutComes

Measure : Weight gain

Time Frame : Baseline, then weekly for 12 weeks

Safety issue : No

Secondary OutComes

Measure : Bioimpedance analysis

Time Frame : Baseline, weeks 6 and 12

Safety issue : No

Measure : Appetite and food intake

Time Frame : 12 weeks

Safety issue : No

Measure : Quality of Life

Time Frame : 12 weeks plus 30 days after study drug stopped

Safety issue : No

Interventions

Type : Drug

Name : Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL

Description : Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)

Type : Drug

Name : Megestrol acetate oral suspension 40 mg/mL

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

Clinical Trial Name - Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-