A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, PEHRG214, in HIV-1-infected individuals

Pett, SL, Williams, LA, Day, RO, Lloyd, AR, Carr, AD, Clezy, KR, Emery, S, Kaplan, E, McPhee, DA, McLachlan, AJ, Gelder, FB, Lewin, SR, Liauw, W and Williams, KM (2004) A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, PEHRG214, in HIV-1-infected individuals. HIV Clinical Trials, 5 2: 91-98. doi:10.1310/1FLN-8KFC-5HEQ-K19J


Author Pett, SL
Williams, LA
Day, RO
Lloyd, AR
Carr, AD
Clezy, KR
Emery, S
Kaplan, E
McPhee, DA
McLachlan, AJ
Gelder, FB
Lewin, SR
Liauw, W
Williams, KM
Title A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, PEHRG214, in HIV-1-infected individuals
Journal name HIV Clinical Trials   Check publisher's open access policy
ISSN 1528-4336
1945-5771
Publication date 2004-01-01
Sub-type Article (original research)
DOI 10.1310/1FLN-8KFC-5HEQ-K19J
Open Access Status Not yet assessed
Volume 5
Issue 2
Start page 91
End page 98
Total pages 8
Place of publication Abingdon, Oxfordshire, United Kingdom
Publisher Taylor & Francis
Language eng
Formatted abstract
Purpose: To establish the pharmacokinetics and safety of single-dose polyclonal caprine anti-HIV antibodies (PEHRG214)in HIV-1--infected individuals. Design: A phase 1, open-label, nonrandomized, dose-escalating study. Method: HIV-1--infected patients with CD4+ T-cell counts of 200 cells/µL and plasma HIV viral load (VL)of 5,000 copies/mL received a single intravenous dose of HRG. Dosing began at 6,000 U/kg HRG with proposed step-wise escalation to 96,000 U/kg. Results: Eleven males were enrolled; median CD4+T-cell count and VL were 96 cells/µL and 126,200 copies/mL, respectively. HRG exhibited linear pharmacokinetics across the dosing range studied. The mean terminal elimination half-life (t1/2)was 136.6 ± 44.6 hours (range, 52.6-198 h).Serum sickness occurred in one 48,000 U/kg HRG recipient. One 6,000 U/kg and two 24,000 U/kg HRG recipients developed a mild rash. Between baseline and day 60,VL remained unchanged (n = 6), increased by 0.67 log10 copies/mL (n = 1), or declined by 0.34-1.55 log10 copies/mL (n = 4). Conclusion: Single-dose HRG exhibited linear kinetics and a long half-life. Although numbers in each dosing group were very small (n = 3), HRG was generally well tolerated in doses below 48,000 U/kg. Multiple dosing with HRG in the HIV-salvage setting may be complicated by immune-complex formation.
Keyword Caprine antibody
Neutralizing
Passive immunotherapy
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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