학술논문
Preliminary safety assessment of CIGB-210, an investigational peptide for HIV infection.
Document Type
Article
Author
Source
Subject
*HIV infections
*ANTI-HIV agents
*FLOW cytometry
*BIOLOGICAL models
*INTERFERON gamma release tests
*CLINICAL drug trials
*ANIMAL experimentation
*INVESTIGATIONAL drugs
*CYTOSKELETAL proteins
*PLACEBOS
*WEIGHT gain
*COMPARATIVE studies
*DESCRIPTIVE statistics
*CELL proliferation
*DRUG development
*STATISTICAL models
*COLORIMETRY
*PEPTIDES
*MICE
*LUMINESCENCE spectroscopy
*PHARMACODYNAMICS
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Language
ISSN
0960-3271
Abstract
Current human immunodeficiency virus treatments need to be periodically administered lifelong. In this study we assess the effect of repeated doses of an anti-HIV peptide drug candidate in C57BL6 strain. Two schemes of up to 15 administrations and one of 30, daily dosing for 5 days per week, all by the subcutaneous route were evaluated. Different dose concentrations of the peptide were assayed. CIGB-210 treated animals showed no symptoms or abnormal behavior as compared with placebo. All the animals gained weight during the study. Macroscopic evaluation showed no alterations in any of the organs studied. Microscopic analysis of the tissues did not show morphological changes in thymus, stomach, small and large intestines, kidney, brain, or cerebellum. The proliferative response of splenocytes and their capacity to secrete gamma interferon were not compromised by the repeated administration of CIGB-210. There were not statistically significant differences for any of the parameters evaluated during the study among treated and non-treated groups. We can conclude that CIGB-210 is well tolerated in C57BL6 mice in the dose concentration range explored and merits subsequent toxicological studies. [ABSTRACT FROM AUTHOR]