Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215852
Status:
TERMINATED
Last Update Posted:
2013-09-04
First Post:
2005-09-16
Brief Title:
A Randomized Dose-ranging Study of Alferon LDO in Asymptomatic HIV Subjects
Sponsor:
AIM ImmunoTech Inc
Organization:
AIM ImmunoTech Inc
Study Overview
Official Title:
A Randomized Dose-Ranging Study of Alferon LDO Low Dose Interferon Alfa-n3 Human Leukocyte Derived in Asymptomatic HIV Subjects
Status:
TERMINATED
Status Verified Date:
2013-08
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 conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels
Detailed Description:
This study will be an open-label randomized outpatient study in HIV infected subjects using a range of doses of Alferon LDO The first nine 9 patients enrolled will not be randomized Instead the first three 3 patients will receive 500 IU the second three 3 patients will receive 1000 IU and the final three 3 patients will receive 2000 IU Once three 3 patients at a given dose level have received at least 8 doses without grade 3 toxicity patients may be enrolled at the next higher dose level Following enrollment of the first nine 9 patients additional patients will be randomized to receive one of the three 3 dose levels of Alferon LDO The Alferon LDO natural interferon alfa-n3 will be in a buffer solution and taken orally once each day for 10 consecutive days at doses equal to 500 IU 1000 IU or 2000 IU
Pretherapy baseline evaluations will be performed within the three 3 week period prior to randomization
Drug will be dispensed for a ten day treatment period during which time any clinical symptoms and adverse events will be evaluated Laboratory samples 25 ml blood for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1 4 and 10 on study days 2 5 and 11 respectively
Pretherapy baseline evaluations will be performed within the three 3 week period prior to randomization
Drug will be dispensed for a ten day treatment period during which time any clinical symptoms and adverse events will be evaluated Laboratory samples 25 ml blood for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1 4 and 10 on study days 2 5 and 11 respectively
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