Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002244
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
Sponsor:
OXO Chemie
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 TCDO Intravenous Solution in the Management of Patients With Late-Stage HIV Disease
Status:
COMPLETED
Status Verified Date:
2001-03
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:
The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease WF10 is suspected to help the immune system fight infection and slow HIV disease progression
Detailed Description:
Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control physiological saline solution Patients are monitored throughout the study for a clinical progression b number duration and cause of hospitalizations c quality of life and d density of CD38 antigen on CD8 T cells Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks During the follow-up period patients are evaluated initially at Week 18 then at Weeks 24 36 and 48 If the study is continued beyond Week 48 follow-up visits are conducted at Weeks 72 and 96
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?: