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Sponsors and Collaborators: |
International Antiviral Therapy Evaluation Center University Medical Centre Groningen Sanquin |
Information provided by: | International Antiviral Therapy Evaluation Center |
ClinicalTrials.gov Identifier: | NCT00128063 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: succinylated human serum albumin |
Phase I Phase II |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 6 |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is one of the following:
Exclusion Criteria:
Netherlands, NH | |||||
Academic Medical Center, University of Amsterdam | |||||
Amsterdam, NH, Netherlands, 1105AZ |
International Antiviral Therapy Evaluation Center |
University Medical Centre Groningen |
Sanquin |
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) |
Related Info 
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Study ID Numbers: | 04-IAT-0047 |
First Received: | August 8, 2005 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00128063 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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