Clinical and laboratory parameters were assessed at baseline, week 24, and week 96. CD4+ T cell count was measured by single- and dual-platform flow cytometry (Becton-Dickinson). HIV-1 RNA in plasma was performed using the COBAS AMPLICOR HIV-1 Monitor Test v1.5 or COBAS TaqMan HIV-1 Test v2.0 (Roche Molecular Systems), with lower limits of quantification (LLQ) of 50 and 20 copies/mL, respectively. CSF samples were run in batch and diluted fourfold for volume requirements for detection of HIV-1 RNA, with an LLQ of 80 copies/mL using the TaqMan platform. HIV-1 RNA measurements below the LLQ that tested positive were designated detectable but not quantifiable. Neuropsychological testing was performed at standardized intervals at weeks 0, 12, 24, and 96 [11 (link)].
Protocol detail
Longitudinal Neuroimmune Monitoring in HIV
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Corresponding Organization : Yale University
Other organizations : Thai Red Cross Society, Walter Reed Army Institute of Research, Henry M. Jackson Foundation, HIV Netherlands Australia Thailand Research Collaboration, Chulalongkorn University, Missouri Institute of Mental Health, University of Missouri–St. Louis, Center for Neurosciences, University of California, San Francisco, Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centers, University of Amsterdam
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Variable analysis
independent variables
- Time points (baseline, week 24, week 96)
- CD4+ T cell count
- HIV-1 RNA in plasma
- HIV-1 RNA in CSF
- Neuropsychological testing
- Not explicitly mentioned
- Positive control: Not mentioned
- Negative control: Not mentioned
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