Adv Pediatr Infect Dis. 1996;12:297-323. Unique Identifier : AIDSLINE
Tools for evaluating antiretroviral therapy are still evolving. Key
components are available such as the laboratory assays themselves, but
results from these assays are being analyzed and presented
inconsistently, making interstudy comparisons difficult or impossible.
In part, the problems in analysis and presentation reflect a lack of
completed clinical trials in which new laboratory methods such as RNA
copy numbers can be validated. Survival is the clearest valid end point
in clinical trials of antiretroviral drugs. Beyond life and death, the
next most important issue is quality of life. Because of the difficulty
in agreeing what "quality of life" means, and the even greater problems
measuring such an abstract concept, in most cases assessments are made
of more quantifiable clinical elements: cognitive and motor function,
growth, and the frequency of opportunistic infections. Laboratory
markers of disease progression are very quantifiable but have meaning
only when they predict clinical outcome. There is a consensus that CD4+
counts, CD4+ percentages, and HIV copy numbers measured by RNA PCR are
important. There is not, however, a consensus approach to interpretation
of data from any of these markers of HIV disease, particularly because
the interpretation may vary based on the patient's level of clinical
disease. With time and more clinical trials with which to clarify their
use, these tools should become more uniformly applied, at which point
cross-study comparisons might be possible. Progress is already being
made in the development of new antiretroviral therapies, and with
improved evaluation techniques the evolution of new anti-HIV treatments
should become an even more efficient process.
*Anti-HIV Agents/THERAPEUTIC USE *HIV Infections/DRUG THERAPY