Evaluation of new anti-infective drugs for the treatment of infection with human immunodeficiency virus. The European Working Party of the European Society of Clinical Microbiology and Infectious Diseases.

Academic Article

Abstract

  • This guideline describes the preclinical documentation required for a new drug active against human immunodeficiency virus (HIV) and offers suggestions regarding the design and implementation of phase 1, 2, and 3 clinical trials. Drugs with a low level of potential toxicity, especially those that are not nucleoside analogues, should be evaluated in healthy individuals who are not infected with HIV before trials in HIV-infected patients commence. The guideline also discusses possible clinical and laboratory end points for efficacy and emphasizes the need for careful validation of all laboratory end points used. The approach of the guideline is deliberately general: more specific recommendations would soon become outdated in this field, which is characterized by extremely rapid developments.
  • Published In

    Keywords

  • Anti-Infective Agents, Clinical Trials as Topic, Drug Evaluation, HIV Infections, Humans, Research Design
  • Digital Object Identifier (doi)

    Author List

  • Norrby SR; Whitley RJ
  • Start Page

  • 794
  • End Page

  • 801
  • Volume

  • 17
  • Issue

  • 4