Standardization of Quantitative Virological Assays for Antiretroviral Clinical Trials

Autor: Janet L. Lathey
Rok vydání: 2014
Předmět:
Zdroj: Journal of Human Virology & Retrovirology. 1
ISSN: 2373-6453
DOI: 10.15406/jhvrv.2014.01.00013
Popis: The AIDS Clinical Trial Group (ACTG) was formed and funded by the National Institute of Allergy and Infectious Diseases (NIAID) in 1987 to enable multi-center clinical trials for the evaluation of treatments for HIV. As there were no licensed anti-retroviral drugs at that time large numbers of subjects and many testing sites were needed to adequately demonstrate clinical efficacy and make the drugs available for general treatment. Initially trial endpoints were based on evaluation of symptoms some of which were based on subjective judgment by clinicians. Measurements of CD4 positive cells were used to demonstrate progression from asymptomatic to symptomatic disease to AIDS. In order to shorten the length of the trials and obtain objective results it was necessary to identify virus specific markers of efficacy. Some of the first viral markers to be evaluated included HIV-1 p24 antigen as measured in serum, and the infectious outgrowth of HIV from peripheral blood mononuclear cells (PBMCs). These tests paved the way for more sensitive tests using HIV nucleic acid amplification to determine the copies of HIV genome in plasma. HIV RNA continues to be the best surrogate marker used today to evaluate the efficacy of new combinations of antiretroviral drugs.
Databáze: OpenAIRE