PMID: 8595508Jan 1, 1995Paper

Current HIV clinical trial design issues

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association
J Lange

Abstract

Aids-free time and survival time of people with HIV infection has gradually increased since the first clinical trial of zidovudine(AZT) in 1987. This change in pattern of disease course has, however, made it difficult for current clinical trials to rely on "hard" clinical end points, such as progression to AIDS or death, to demonstrate antiretroviral efficacy. These trials must continue for a number of years and enroll large numbers of patients; as a result, maintaining patients on protocolled therapy is difficult to achieve. Furthermore, patients can be prevented from reaching clinical end points by prophylaxis of opportunistic infections. Combined with the move toward treating individuals earlier in the course of infection, current clinical trials using "hard" clinical end points are unlikely to demonstrate drug efficacy. The concept of using "soft" clinical end points and laboratory end points such as decline in CD4 cell count to a threshold value, was first introduced in study EACG 020 of patients with early stage infection, and made it possible for this study to demonstrate the efficacy of AZT in this patient population. Further accurate markers of disease progression are required for current clinical trials. There is grow...Continue Reading

Citations

Dec 14, 2011·Current Infectious Disease Reports·Katherine Huppler Hullsiek, Birgit Grund
Nov 6, 1998·British Journal of Clinical Pharmacology·C Minto, T Schnider
Dec 12, 2001·Controlled Clinical Trials·V JournotUNKNOWN ALBI Study Group
Jul 1, 1997·Memórias do Instituto Oswaldo Cruz·M C Portela, K N Simpson
Dec 2, 1998·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·D B JeffeV J Fraser

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