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

NCT ID: NCT00637572

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-06-30

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

Conditions

HIV Infections; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Megestrol acetate oral suspension nanocrystal dispersion

Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL

Group Type: EXPERIMENTAL

Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL

Intervention Type: DRUG

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

Megestrol acetate oral suspension micronized formulation

Megestrol acetate oral suspension micronized formulation 60 mg/mL

Group Type: ACTIVE_COMPARATOR

Megestrol acetate oral suspension 40 mg/mL

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Megestrol acetate oral suspension 40 mg/mL

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

Intervention Type: DRUG

Other Intervention Names

Megace ES; Megace

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Fourie, MD

Role: PRINCIPAL_INVESTIGATOR

58 Ann Street, Dundee, KZ-Natal 3000, S. Africa

Locations

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Victoria Hospital

Bangalore, Karnataka, India

M.S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

Kasturba Medical College

Mangalore, Karnataka, India

Ruby Hall Clinic and Grant Medical Foundation

Pune, Maharashtra, India

St Mary's Hospital

Private Bag, Ashwood, South Africa

Quinta-research

Pellissier, Bloemfontein, South Africa

Genclin Corporation, Clinical Trial Centre

Westdene, Bloemfontein, South Africa

40 Arthur Hobbs Street

Boksburg, Johannesburg, South Africa

6 Calypso Centre

Richards Bay, KwaZulu-Natal, South Africa

Eastmed Hospital

Eastlynn, Pretoria, South Africa

TrialTech Clinical Research

Hatfield, Pretoria, South Africa

Countries

United States; India; South Africa

References

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

Reference Type: RESULT

Related Links

http://jrnlappliedresearch.com/articles/index.htm

Link to published study

Other Identifiers

PAR-002

Identifier Type: -

Identifier Source: org_study_id