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

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Involuntary Weight Loss; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome

Intervention: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL (Drug); Megestrol acetate oral suspension 40 mg/mL (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Jan Fourie, MD, Principal Investigator, Affiliation: 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Weight gain

Secondary outcome:

Bioimpedance analysis

Appetite and food intake

Quality of Life


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


- Current evidence of or history of diabetes mellitus or hypoadrenalism

- Systemic treatment with glucocorticoids within the 12 months prior to study entry

Locations and Contacts

St Mary's Hospital, Private Bag, Ashwood 3605, South Africa

Quinta-research, Pellissier, Bloemfontein 9317, South Africa

Genclin Corporation, Clinical Trial Centre, Westdene, Bloemfontein 9301, South Africa

40 Arthur Hobbs Street, Boksburg, Johannesburg 1466, South Africa

M.S. Ramaiah Medical College and Hospital, Bangalore, Karnataka 560054, India

Victoria Hospital, Bangalore, Karnataka 560002, India

Kasturba Medical College, Mangalore, Karnataka 575003, India

6 Calypso Centre, Richards Bay, Kwazulu Natal 3900, South Africa

Ruby Hall Clinic and Grant Medical Foundation, Pune, Maharashtra 411001, India

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States

Eastmed Hospital, Eastlynn, Pretoria 0186, South Africa

TrialTech Clinical Research, Hatfield, Pretoria 0001, South Africa

Additional Information

Link to published study

Starting date: December 2004
Last updated: August 17, 2015

Page last updated: August 23, 2015

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