Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials: Issues in interim monitoring and early stopping

R. Zackin, I. Marschner, J. Andersen, M. K. Cowles, V. De Gruttola, S. Hammer, Margaret A Fischl, D. Cotton

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Due to the desire to both shorten the length and reduce the size of clinical trials in human immunodeficiency virus (HIV) disease, the use of surrogate end points such as HIV-1 RNA is becoming increasingly standard. While these end points may be reasonable surrogates for the clinical effectiveness of drugs, a key point in their use as trial end points is the definition of a relevant duration of antiviral response. This definition is often complicated by the desire to perform interim reviews of ongoing laboratory end point trials. Unlike clinical end point trials, in which early clinical response is generally indicative of longer-term follow-up, it is yet to be determined whether short-term viral response adequately predicts the long-term durability of that response.

Original languageEnglish
Pages (from-to)761-765
Number of pages5
JournalJournal of Infectious Diseases
Volume177
Issue number3
StatePublished - Jan 1 1998
Externally publishedYes

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Virus Diseases
Antiviral Agents
HIV-1
Biomarkers
Clinical Trials
HIV
RNA
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology
  • Public Health, Environmental and Occupational Health

Cite this

Zackin, R., Marschner, I., Andersen, J., Cowles, M. K., De Gruttola, V., Hammer, S., ... Cotton, D. (1998). Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials: Issues in interim monitoring and early stopping. Journal of Infectious Diseases, 177(3), 761-765.

Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials : Issues in interim monitoring and early stopping. / Zackin, R.; Marschner, I.; Andersen, J.; Cowles, M. K.; De Gruttola, V.; Hammer, S.; Fischl, Margaret A; Cotton, D.

In: Journal of Infectious Diseases, Vol. 177, No. 3, 01.01.1998, p. 761-765.

Research output: Contribution to journalArticle

Zackin, R, Marschner, I, Andersen, J, Cowles, MK, De Gruttola, V, Hammer, S, Fischl, MA & Cotton, D 1998, 'Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials: Issues in interim monitoring and early stopping', Journal of Infectious Diseases, vol. 177, no. 3, pp. 761-765.
Zackin R, Marschner I, Andersen J, Cowles MK, De Gruttola V, Hammer S et al. Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials: Issues in interim monitoring and early stopping. Journal of Infectious Diseases. 1998 Jan 1;177(3):761-765.
Zackin, R. ; Marschner, I. ; Andersen, J. ; Cowles, M. K. ; De Gruttola, V. ; Hammer, S. ; Fischl, Margaret A ; Cotton, D. / Human immunodeficiency virus type 1 (HIV-1) RNA end points in HIV clinical trials : Issues in interim monitoring and early stopping. In: Journal of Infectious Diseases. 1998 ; Vol. 177, No. 3. pp. 761-765.
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