Succinylated Human Serum Albumin (Suc-HSA) for HIV-1 Infection
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|ClinicalTrials.gov Identifier: NCT00128063|
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : April 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: succinylated human serum albumin||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2005|
|Study Completion Date :||June 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128063
|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)|