A phase I/IIa study with succinylated human serum albumin (Suc-HSA), a candidate HIV-1 fusion inhibitor

Antiviral Therapy

Volumn 12, Issue 2, 2007, Pages 273-278

  Vermeulen, Joost N ^a,b   Meijer, Dirk K F ^c   Over, Jan ^d   Lange, Joep M A ^a,b   Proost, Johannes H ^c   Bakker, Hester I ^c   Beljaars, Leonie ^c   Wit, Ferdinand W N M ^a,b   Prins, Jan M ^b  

^a IATEC   (Netherlands)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c UNIVERSITY OF GRONINGEN   (Netherlands)

^d Sanquin Plasmaproducten   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; HUMAN SERUM ALBUMIN SUCCINATE; NEOGLYCOPROTEIN; UNCLASSIFIED DRUG; VIRUS RNA;

ADULT; AGED; ARTICLE; CD4+ T LYMPHOCYTE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LABORATORY TEST; LYMPHOCYTE COUNT; MALE; MULTIPLE DRUG DOSE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; CD4 LYMPHOCYTE COUNT; DRUG ADMINISTRATION SCHEDULE; FEMALE; HIV FUSION INHIBITORS; HIV INFECTIONS; HIV-1; HUMANS; INJECTIONS, INTRAVENOUS; LIVER DISEASES; MALE; MIDDLE AGED; RNA, VIRAL; SERUM ALBUMIN; SUCCINIC ACIDS; TREATMENT FAILURE; VIRAL LOAD;

EID: 34147123734     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. Palella FJJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853-860.
2. Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet 2000; 356:1423-1430.
3. Richman DD, Morton SC, Wrin T, et al. The prevalence of antiretroviral drug resistance in the United States. AIDS 2004; 18:1393-1401.
4. Meijer DK, Heeswijk RPGv, Swart PJ, et al. Charge-modified plasma and milk proteins that interfere with HIV and CMV/target cell binding and fusion. Recent Res Devel Antiviral Res 2001; 1:81-115.
5. Kuipers ME, Huisman JG, Swart PJ, et al. Mechanism of anti-HIV activity of negatively charged albumins: biomolecular interaction with the HIV-1 envelope protein gp120. J Acquir Immune Defic Syndr Hum Retrovirol 1996; 11:419-429.
6. Kuipers ME. Binding of negatively charged human serum albumins to lymphocytes: implications for their anti-HIV effects and NCA mediated drug targeting to lymphocytes. PhD thesis 1996; 59-72. University of Groningen, Groningen, the Netherlands.
7. Groenink M, Swart PJ, Broersen S, Kuipers M, Meijer DK, Schuitemaker H. Potent inhibition of replication of primary HIV type 1 isolates in peripheral blood lymphocytes by negatively charged human serum albumins. AIDS Res Hum Retroviruses 1997; 13:179-185.
8. Swart PJ, Kuipers ME, Smit C, et al. Antiviral effects of milk proteins: acylation results in polyanionic compounds with potent activity against human immunodeficiency virus types 1 and 2 in vitro. AIDS Res Hum Retroviruses 1996; 12:769-775.
9. Cabrera C, Witvrouw M, Gutierrez A, et al. Resistance of the human immunodeficiency virus to the inhibitory action of negatively charged albumins on virus binding to CD4. AIDS Res Hum Retroviruses 1999; 15:1535-1543.
10. Jansen RW, Schols D, Pauwels R, De Clercq E, Meijer DK. Novel, negatively charged, human serum albumins display potent and selective in vitro anti-human immunodeficiency virus type 1 activity. Mol Pharmacol 1993; 44:1003-1007.
11. Kuipers ME, Swart PJ, Schutten M, et al. Pharmacokinetics and anti-HIV-1 efficacy of negatively charged human serum albumins in mice. Antiviral Res 1997; 33:99-108.
12. Swart PJ, Beljaars E, Smit C, Pasma A, Schuitemaker H, Meijer DK. Comparative pharmacokinetic, immunologic and hematologic studies on the anti-HIV-1/2 compounds aconitylated and succinylated HSA. J Drug Target 1996; 4:109-116.
13. Swart PJ, Schutten M, Smit C, et al. Pharmacokinetics of succinylated serum albumin in wistar rats and cynomolgus monkeys: implications for dosage regimens in the therapy of HIV Infection. Drug Delivery 1996; 3:165-171.
14. Swart PJ, Kuipers ME, Smit C, Beljaars L, Ter Wiel J, Meijer DK. The metabolic fate of the Anti-HIV active drug carrier succinylated human serum albumin after intravenous administration in rats. J Drug Target 2001; 9:95-109.
15. Swart PJ, Beljaars L, Kuipers ME, Smit C, Nieuwenhuis P, Meijer DK. Homing of negatively charged albumins to the lymphatic system: general implications for drug targeting to peripheral tissues and viral reservoirs. Biochem Pharmacol 1999; 58:1425-1435.
16. Jansen RW, Olinga P, Harms G, Meijer DK. Pharmacokinetic analysis and cellular distribution of the anti-HIV compound succinylated human serum albumin (Suc-HSA) in vivo and in the isolated perfused rat liver. Pharm Res 1993; 10:1611-1614.
17. Proost JH, Beljaars L, Olinga P, et al. Prediction of the pharmacokinetics of succinylated human serum albumin in man from in vivo disposition data in animals and in vitro liver slice incubations. Eur J Pharm Sci 2006; 27:123-132.