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

NCT00637572 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-10-05

Study results available
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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

Interventions

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)

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)

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jan Fourie, MD · 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States
  • India
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637572 on ClinicalTrials.gov