Eve K. Nichols

Mobilizing Against Aids, Revised and Enlarged Edition Eve K. Nichols 2nd edition

This historic book may have numerous typos and missing text. Purchasers can download a free scanned copy of the original book (without typos) from the publisher. Not indexed. Not illustrated. 1986-07 edition. Excerpt: ...drug's safety in humans and to begin determination of appropriate dose levels and routes of administration. In phase II trials researchers gather additional information about the most effective way to administer the drug and about possible adverse effects, and they begin to assess its clinical potential. Phase III clinical trials are controlled field studies with larger numbers of patients to develop reasonable estimates of safety and efficacy. Two approaches have been used by scientists in the United States and abroad to accelerate the development of anti-AIDS drugs without bypassing established testing procedures. The first has been to examine the susceptibility of HTLV-III/LAV to drugs originally developed for other purposes. The benefit of this approach is that researchers can bypass toxicity studies in animal models and some of the early stages of clinical trials because they already know how the drug affects human tissues. The second approach has been to develop rapid screening systems for new chemical agents, followed by carefully monitored laboratory and early clinical studies of any promising candidates. In the United States this process has been characterized by ongoing collaborations involving scientists from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, numerous academic medical centers, and the pharmaceutical industry. Constant communication between research scientists and the FDA has accelerated this process even further. Drugs Developed for Other Purposes A variety of existing antiviral drugs have been found to inhibit HTLV-III/LAV in the laboratory, but clinical results have been discouraging. Although some have been shown to reduce viral replication in patients with AIDS, they do not...