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

Endo Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

HIV Wasting Syndrome

Anorexia

Cachexia

AIDS Wasting Syndrome

HIV Infections

Treatments

Drug: Megestrol acetate oral suspension 40 mg/mL

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00637572

PAR-002

Details and patient eligibility

About

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

Enrollment

63 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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