Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002254
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multi-Center Open-Label Ascending Multiple Oral Dose Safety Tolerance and Pharmacokinetic Study of 3-Deoxy-3-Fluorothymidine FLT in Patients With Acquired Immune Deficiency Syndrome AIDS or AIDS-Related Complex ARC
Sponsor:
Lederle Laboratories
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multi-Center Open-Label Ascending Multiple Oral Dose Safety Tolerance and Pharmacokinetic Study of 3-Deoxy-3-Fluorothymidine FLT in Patients With Acquired Immune Deficiency Syndrome AIDS or AIDS-Related Complex ARC
Status:
COMPLETED
Status Verified Date:
1991-05
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 tolerance and toxicity profile of deoxy-3-fluorothymidine FLT after multiple oral dosing for 16 weeks To characterize the steady-state pharmacokinetics of FLT after multiple oral doses To assess the effect of FLT on immunologic and virologic markers of HIV infection CD4 lymphocyte count p24 antigen viremia in patients with AIDS or AIDS related complex ARC after multiple oral dosing for 16 weeks
Detailed Description:
None
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 81-2 | None | None | None |