Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128063
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-08-08
Brief Title:
Succinylated Human Serum Albumin Suc-HSA for HIV-1 Infection
Sponsor:
International Antiviral Therapy Evaluation Center
Organization:
International Antiviral Therapy Evaluation Center
Study Overview
Official Title:
A Phase 1 2 Randomized Open-Label Study to Evaluate the Pharmacokinetics Safety and Antiretroviral Activity of Succinylated Human Serum Albumin Suc-HSA in Treatment Naïve HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2007-04
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 primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily intravenous iv doses The secondary objectives are to evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily iv doses of Suc-HSA
Detailed Description:
This is a single centre single arm study Subjects will receive 5 consecutive daily doses of Suc-HSA at a dose of 10 mgkg on days 0 1 2 3 and 4 on the Special Investigation Unit SIU with a safety follow up on the SIU for 4 hours on day 1 and 2 hours on the next days There will be follow-up visits on week 1 2 4 and 12 Standard safety parameters physical examination clinical symptoms laboratory hematology and biochemistry will be followed until week 12 Plasma HIV-1 RNA and CD4CD8 cell counts will be assessed at every visit Plasma drug levels trough and peak will be measured from baseline until week 2
6 patients will be included in this study as described in this protocol amendment
Eligible subjects are chronic HIV-1 infected patients who have never been treated with antiretroviral treatment and for whom there is no need to start antiretroviral treatment
Test Product Suc-HSA a candidate HIV-1 fusion inhibitor
Duration of treatment 5 days
Criteria for evaluation
Safety symptoms signs at physical examination standard hematology and chemistry laboratory parameters- Efficacy changes in plasma HIV-1 RNA and CD4 T cell count
Pharmacokinetics plasma levels of Suc-HSA Cmin Cmax and AUC
6 patients will be included in this study as described in this protocol amendment
Eligible subjects are chronic HIV-1 infected patients who have never been treated with antiretroviral treatment and for whom there is no need to start antiretroviral treatment
Test Product Suc-HSA a candidate HIV-1 fusion inhibitor
Duration of treatment 5 days
Criteria for evaluation
Safety symptoms signs at physical examination standard hematology and chemistry laboratory parameters- Efficacy changes in plasma HIV-1 RNA and CD4 T cell count
Pharmacokinetics plasma levels of Suc-HSA Cmin Cmax and AUC
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