Trial record 3 of 32 for:    " February 20, 2008":" March 21, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637572
First received: March 11, 2008
Last updated: April 1, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
HIV Infections
Unintended Weight Loss
Cachexia
Anorexia
AIDS Wasting Syndrome
HIV Wasting Syndrome
Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Weight gain [ Time Frame: Baseline, then weekly for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bioimpedance analysis [ Time Frame: Baseline, weeks 6 and 12 ] [ Designated as safety issue: No ]
  • Appetite and food intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12 weeks plus 30 days after study drug stopped ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: December 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Megestrol acetate oral suspension nanocrystal dispersion formulation
Drug: 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)
Other Name: Megace ES
Active Comparator: 2
Megestrol acetate oral suspension micronized formulation
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)
Other Name: Megace

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637572

Locations
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India, 560054
Victoria Hospital
Bangalore, Karnataka, India, 560002
Kasturba Medical College
Mangalore, Karnataka, India, 575003
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India, 411001
South Africa
St Mary's Hospital
Private Bag, Ashwood, South Africa, 3605
Quinta-research
Pellissier, Bloemfontein, South Africa, 9317
Genclin Corporation, Clinical Trial Centre
Westdene, Bloemfontein, South Africa, 9301
40 Arthur Hobbs Street
Boksburg, Johannesburg, South Africa, 1466
6 Calypso Centre
Richards Bay, Kwazulu Natal, South Africa, 3900
Eastmed Hospital
Eastlynn, Pretoria, South Africa, 0186
TrialTech Clinical Research
Hatfield, Pretoria, South Africa, 0001
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Quintiles
Investigators
Principal Investigator: Jan Fourie, MD 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
  More Information

Additional Information:
Publications:
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

Responsible Party: VP Clinical and Medical Affairs, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier: NCT00637572     History of Changes
Other Study ID Numbers: PAR-002
Study First Received: March 11, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
HIV wasting
Weight loss
Cachexia
Anorexia
Megestrol acetate oral suspension
Nanocrystal dispersion
Nanocrystal technology
Body weight changes
AIDS wasting
Emaciation
Megace ES
Megace
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Wasting Syndrome
Anorexia
Cachexia
Wasting Syndrome
Weight Gain
Weight Loss
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents

ClinicalTrials.gov processed this record on September 14, 2014