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NLM AIDSLINE
Clinical trials and viral load: statement for FDA community meeting May 16. Food and Drug Administration.
James JS; Clearinghouse, AIDS Newsletter Database, P.O. Box 6003,
September 30, 1997
AIDS Treat News. 1997 May 16;(No 271):1-4. Unique Identifier : AIDSLINE

A statement written for a May 16, 1997 Food and Drug Administration (FDA) community forum discusses the advantages of maintaining undetectable viral load levels as the primary way to judge the efficacy of an antiretroviral drug regimen in confirmatory trials. It is becoming clear that some degree of viral load suppression, for some period of time, should be required for final drug therapy approval. A protocol requiring frequent viral load testing should be used to detect failing regimens, however, treatment failure would not be declared from a single viral load result. Exact criteria for virological failure, either loss of complete suppression after it had been achieved, or an inability to achieve it in the first place, would be defined in the protocol. The advantages of using this type of endpoint protocol are listed and the reasons for needing regulatory oversight are discussed.

*Acquired Immunodeficiency Syndrome/DRUG THERAPY *Clinical Trials/LEGISLATION & JURISPRUD *Viral Load

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