Journal article
Anti-HIV-1 Activity of Weekly or Biweekly Treatment with Subcutaneous PRO 140, a CCR5 Monoclonal Antibody
The Journal of infectious diseases, v 201(10), pp 1481-1487
15 May 2010
PMID: 20377413
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background
. PRO 140 is a humanized CCR5 monoclonal antibody that has demonstrated potent antiviral activity when it is administered intravenously to adults infected with CCR5-tropic (R5) human immunodeficiency virus type 1 (HIV-1). This study is the first to evaluate subcutaneous administration.
Methods
. A randomized, double-blind, placebo-controlled study was conducted among 44 subjects with HIV-1 RNA levels of >5000 copies/mL, CD4+ cell counts of >300 cells/µL, no receipt of antiretroviral therapy for ⩾12 weeks, and only R5 HIV-1 detectable. Subjects received placebo, 162 mg of PRO 140, or 324 mg of PRO 140 weekly for 3 weeks or 324 mg of PRO 140 every other week for 2 doses by means of subcutaneous infusion. Subjects were monitored for 58 days for safety, antiviral effects, and PRO 140 serum concentrations.
Results
. Subcutaneous PRO 140 demonstrated potent and prolonged antiretroviral activity. Mean log10 reductions in HIV-1 RNA level were 0.23, 0.99 ( P = .009), 1.37 (P<.001), and 1.65 (P<.001) for the placebo, 162 mg weekly, 324 mg biweekly, and 324 mg weekly dose groups, respectively. Viral loads remained suppressed between successive doses. Treatment was generally well tolerated.
Conclusions
. This trial demonstrates proof of concept for a monoclonal antibody administered subcutaneously in HIV-1 infected individuals. Subcutaneous PRO 140 offers the potential for significant dose-dependent HIV-1 RNA suppression and infrequent patient self-administration.
Trial registration
. ClinicalTrials.gov identifier: NCT00642707.
Metrics
Details
- Title
- Anti-HIV-1 Activity of Weekly or Biweekly Treatment with Subcutaneous PRO 140, a CCR5 Monoclonal Antibody
- Creators
- Jeffrey M Jacobson - Drexel UniversityMelanie A Thompson - AIDS Research Consortium of AtlantaJacob P Lalezari - Quest Clinical ResearchMichael S Saag - University of Alabama at BirminghamPaul Zingman - Montefiore Medical Center and Einstein/Montefiore Center for AIDS ResearchBarry S D'Ambrosio - Progenics PharmaceuticalsNancy Stambler - Progenics PharmaceuticalsYakov Rotshteyn - Progenics PharmaceuticalsAndre J Marozsan - Progenics PharmaceuticalsPaul J Maddon - Progenics PharmaceuticalsStephen A Morris - Progenics PharmaceuticalsWilliam C Olson - Progenics PharmaceuticalsMarla A Thompson - College of Engineering (1970-)
- Publication Details
- The Journal of infectious diseases, v 201(10), pp 1481-1487
- Publisher
- The University of Chicago Press
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Engineering
- Web of Science ID
- WOS:000276767600007
- Scopus ID
- 2-s2.0-77951916324
- Other Identifier
- 991019169638904721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Immunology
- Infectious Diseases
- Microbiology