Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002345
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Megace in HIV-Infected Women
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To further evaluate the safety of megestrol acetate Megace oral suspension in the treatment of anorexia and cachexia in HIV-positive women To compare the effectiveness of 2 doses of Megace by measurement of weight gain appetite grade and other parameters at 12 and 24 weeks
Detailed Description:
Patients are randomized to receive 1 of 2 doses of Megace oral suspension daily for 24 weeks at 12 weeks those receiving the lower dose who have not gained 5 pounds over baseline or had appetite improvement to good or excellent are escalated to the higher dose Patients are evaluated at 4-week intervals Dose may be adjusted to maintain a desired weight
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MEG169-93007 | None | None | None |