Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002335
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of 524W91
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Randomized Single-Dose Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91
Status:
COMPLETED
Status Verified Date:
1996-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients To determine the effects of food on bioavailability of 524W91
Detailed Description:
Patients are randomized to receive six single escalating doses of 524W91 or placebo with each dose separated by at least a 6-day washout interval In the time between 2 of the doses the effect of food on pharmacokinetics will be investigated with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: