Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251537
Status:
COMPLETED
Last Update Posted:
2006-07-10
First Post:
2005-11-09
Brief Title:
A Pilot Study of LTB4 in HIV-1 Infected Adults
Sponsor:
LTB4 Sweden AB
Organization:
LTB4 Sweden AB
Study Overview
Official Title:
A Pilot Study Assessing Safety and Antiretroviral Activity of Intravenously Administered LTB4 in HIV-1 Infected Adults With a CD4 Count Greater Than 250 Cellsmm3 and a Viral Load Greater Than 5000 CopiesmL and Who Have Not Received Antiretroviral Therapy Within Two Months
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This is a pilot study to assess the safety and antiretroviral activity of a naturally occuring substance known as Leukotriene B4LTB4 The aim of the study is to determine the effect of LTB4 on viral load during a period of 6 weeks 4 weeks of active treatment and 2 additional weeks after the end of active treatment for safety follow-up 40 patients in seven clinics in Canada will be randomized into three treatment arms either of two doses of LTB4 or placebo Study drug is administered intravenously once daily LTB4 can activate and stimulate various white blood cells and by the activation release natural substances in the body and this process is an important part of the bodys defense against infections
Detailed Description:
The objective of this pilot study is to investigate whether LTB4 administered at a dose that provides an increase in alfa-defensin release from neutrophils can affect HIV viral load in HIV-1 infected individuals The safety tolerability and effect will be assessed of 28 days of daily intravenous dosing of LTB4 on HIV viral load Safety and tolerability will also be assessed
The study is randomized double-blind placebo controlled All subjects will be randomly assigned to one of three treamtent groups LTB4 at two different dose levels or corresponding placebo Treatment duration is 4 weeks and follow-up period is 2 weeks Subjects will visit the clinic on a daily basis during the treatment period to receive a daily intravenous injection of the study drug 40 subjects will be enrolled seven clinics in Canada will participate in the study
Primary endpoint Change in viral load over the treatment period of 28 days Secondary endpoint CD4 CD8 and neutrophil counts alfa-defensins and CC-che mokine release in blood
The study is randomized double-blind placebo controlled All subjects will be randomly assigned to one of three treamtent groups LTB4 at two different dose levels or corresponding placebo Treatment duration is 4 weeks and follow-up period is 2 weeks Subjects will visit the clinic on a daily basis during the treatment period to receive a daily intravenous injection of the study drug 40 subjects will be enrolled seven clinics in Canada will participate in the study
Primary endpoint Change in viral load over the treatment period of 28 days Secondary endpoint CD4 CD8 and neutrophil counts alfa-defensins and CC-che mokine release in blood
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