Succinylated Human Serum Albumin (Suc-HSA) for HIV-1 Infection
The primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily intravenous (i.v.) doses. The secondary objectives are to evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily i.v. doses.
- To evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.
|Study Start Date:||August 2005|
|Study Completion Date:||June 2006|
This is a single centre, single arm study. Subjects will receive 5 consecutive daily doses of Suc-HSA at a dose of 10 mg/kg 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 CD4+/CD8+ 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
|Academic Medical Center, University of Amsterdam|
|Amsterdam, NH, Netherlands, 1105AZ|
|Study Chair:||Joep MA Lange, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Jan Prins, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|