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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Quintiles |
---|---|
Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00637572 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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) |
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 |
---|---|
1: Experimental
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)
|
2: Active Comparator
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)
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102 | |
India, Karnataka | |
M.S. Ramaiah Medical College and Hospital | |
Bangalore, Karnataka, India, 560054 | |
Kasturba Medical College | |
Mangalore, Karnataka, India, 575003 | |
Victoria Hospital | |
Bangalore, Karnataka, India, 560002 | |
India, Maharashtra | |
Ruby Hall Clinic and Grant Medical Foundation | |
Pune, Maharashtra, India, 411001 | |
South Africa, Ashwood | |
St Mary's Hospital | |
Private Bag, Ashwood, South Africa, 3605 | |
South Africa, Bloemfontein | |
Genclin Corporation, Clinical Trial Centre | |
Westdene, Bloemfontein, South Africa, 9301 | |
Quinta-research | |
Pellissier, Bloemfontein, South Africa, 9317 | |
South Africa, Johannesburg | |
40 Arthur Hobbs Street | |
Boksburg, Johannesburg, South Africa, 1466 | |
South Africa, Kwazulu Natal | |
6 Calypso Centre | |
Richards Bay, Kwazulu Natal, South Africa, 3900 | |
South Africa, Pretoria | |
TrialTech Clinical Research | |
Hatfield, Pretoria, South Africa, 0001 | |
Eastmed Hospital | |
Eastlynn, Pretoria, South Africa, 0186 |
Principal Investigator: | Jan Fourie, MD | 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa |
Responsible Party: | Par Pharmaceutical, Inc ( VP Clinical and Medical Affairs ) |
Study ID Numbers: | PAR-002 |
Study First Received: | March 11, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00637572 |
Health Authority: | United States: Food and Drug Administration |
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 |
Sexually Transmitted Diseases, Viral Metabolic Diseases Signs and Symptoms, Digestive HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Cachexia Emaciation Weight Gain Megestrol Immunologic Deficiency Syndromes Virus Diseases Body Weight |
Signs and Symptoms HIV Infections Sexually Transmitted Diseases Weight Loss Anorexia Body Weight Changes Nutrition Disorders Metabolic disorder Wasting Syndrome Retroviridae Infections Megestrol Acetate |
RNA Virus Infections Slow Virus Diseases Disease Immune System Diseases Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Central Nervous System Stimulants |
Reproductive Control Agents Infection Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Lentivirus Infections Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |