Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004987
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-03-16
Brief Title:
Treatment of Advanced AIDS Patients With Dextrin Sulfate
Sponsor:
Steinhart Medical Associates
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease A Phase I Trial
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment
Detailed Description:
Patients have intraperitoneal IP catheter placement done at study entry Infusion with the carrier vehicle icodextrin 4 begins 2 weeks later and 2 days after that treatment with dextrin sulphate DS commences DS is given three times per week A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks Patient evaluations are done regularly during treatment and observation continues for 24 weeks
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?: