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

NCT00637572 | Completed Phase 2 Results

• 1 other identifier: PAR-002
• Study Type: interventional
• Target: 63
• Locations: 3 countries
• Sites: 12

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment

  Baseline (Day 1) to Week 12

Secondary Outcomes (10)

• Change From Baseline in Lean Mass

  Baseline (Day 1) to Week 12

• Change From Baseline in Impedance

  Baseline (Day 1) to Week 12

• Change From Baseline in Body Fat Mass

  Baseline (Day 1) to Week 12

• Change in Hip Circumference

  Baseline (Day 1) to Week 12

• Change in Waist Circumference

  Baseline (Day 1) to Week 12

Study Arms (2)

Megestrol acetate oral suspension nanocrystal dispersion

EXPERIMENTAL

Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL

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

Megestrol acetate oral suspension micronized formulation

ACTIVE COMPARATOR

Megestrol acetate oral suspension micronized formulation 60 mg/mL

Drug: Megestrol acetate oral suspension 40 mg/mL

Interventions

Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL DRUG

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

Also known as: Megace ES

Megestrol acetate oral suspension nanocrystal dispersion

Megestrol acetate oral suspension 40 mg/mL DRUG

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

Also known as: Megace

Megestrol acetate oral suspension micronized formulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• Quintiles, Inc.: collaborator

Study Sites (12)

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Victoria Hospital

Bangalore, Karnataka, 560002, India

Location

M.S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, 560054, India

Location

Kasturba Medical College

Mangalore, Karnataka, 575003, India

Location

Ruby Hall Clinic and Grant Medical Foundation

Pune, Maharashtra, 411001, India

Location

St Mary's Hospital

Private Bag, Ashwood, 3605, South Africa

Location

Quinta-research

Pellissier, Bloemfontein, 9317, South Africa

Location

Genclin Corporation, Clinical Trial Centre

Westdene, Bloemfontein, 9301, South Africa

Location

40 Arthur Hobbs Street

Boksburg, Johannesburg, 1466, South Africa

Location

6 Calypso Centre

Richards Bay, KwaZulu-Natal, 3900, South Africa

Location

Eastmed Hospital

Eastlynn, Pretoria, 0186, South Africa

Location

TrialTech Clinical Research

Hatfield, Pretoria, 0001, South Africa

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Link to published study

MeSH Terms

Conditions

HIV Infections; Cachexia; Anorexia; HIV Wasting Syndrome; Weight Loss; Body Weight Changes; Emaciation

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive; Wasting Syndrome; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Jan Fourie, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: December 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: October 5, 2017
• Results First Posted: April 20, 2016

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (7); IN (4); US (1)