Viral load as a primary outcome in human immunodeficiency virus trials: a review of statistical analysis methods

Control Clin Trials. 2001 Dec;22(6):639-58. doi: 10.1016/s0197-2456(01)00158-1.

Abstract

In Human Immunodeficiency Virus infection, several statistical methods are available to analyze viral load (HIV-1 RNA) used as a surrogate outcome in trials of antiretroviral treatments. We compared the most frequently used methods and applied them to one of these trials, where HIV-1 RNA was measured using two lower limits of detection. Methods were reviewed for different properties dealing with validity, interpretation, and handling. Compared to change of HIV-1 RNA at the end of follow-up or HIV-1 RNA area-under-the-curve during follow-up minus baseline, the most attractive methods appeared to be HIV-1 RNA undetectability, HIV-1 RNA reduction at the end of follow-up with censoring adjustment, and mixed linear model on HIV-1 RNA.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Area Under Curve
  • HIV Infections / drug therapy*
  • HIV-1*
  • Humans
  • Linear Models*
  • RNA, Viral / blood
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Treatment Outcome
  • Viral Load*

Substances

  • RNA, Viral
  • Reverse Transcriptase Inhibitors