Stavudine is a potent HIV-1 reverse transcriptase inhibitor licensed in
1994. No systematic evaluation of cerebrospinal fluid stavudine
concentrations has been reported, either for single doses or under
steady-state conditions. Improved understanding of stavudine penetration
into CSF is important because of the desire for adequate inhibitory
concentrations in the central nervous system to suppress HIV replication
and hopefully to prevent or slow the development of the AIDS dementia
complex.
This protocol will examine the concentrations of stavudine (d4T) in
cerebrospinal fluid (CSF) of HIV-infected subjects undergoing elective
lumbar punctures (LP). Two groups of subjects will be studied: 1)
those prescribed stavudine for clinical considerations, who will provide
insight into CSF concentrations achieved under steady-state conditions;
2) those not receiving stavudine clinically, but agreeing to take a
single dose prior to a scheduled LP, who will provide information on
acute dynamics.
This study will also determine whether or not a relationship exists
between patient CD4 cell concentration and efficiency of CSF stavudine
entry and whether or not a relationship exists between CSF white cell
concentration or total protein and the efficiency of CSF stavudine
entry.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS therapyHIV infectionscerebrospinal fluidclinical researchclinical trial phase Idrug screening /evaluationhelper T lymphocytehuman subjecthuman therapy evaluationlumbar puncturepharmacokineticsstavudine
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