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Tracking Information | |
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First Received Date † | November 2, 1999 |
Last Updated Date | October 1, 2007 |
Start Date † | |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00002300 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition |
Official Title † | Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia |
Brief Summary | To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To characterize dose response in relation to weight gain. To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes. |
Detailed Description | |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Double-Blind |
Condition † |
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Intervention † | Drug: Megestrol acetate |
Study Arms / Comparison Groups | |
Publications * | Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62. Review. |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria Patient must have:
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00002300 |
Responsible Party | |
Secondary IDs †† | MEG8807 |
Study Sponsor † | Bristol-Myers Squibb |
Collaborators †† | |
Investigators † | |
Information Provided By | Bristol-Myers Squibb |
Verification Date | October 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |