| Publication Abstract Display | | Type: Published Manuscript | | Title: Meeting practical challenges of a trial involving a multitude of treatment regimens: an example of a multi-center randomized controlled clinical trial in NeuroAIDS. | | Authors: May S, Letendre S, Haubrich R, McCutchan JA, Heaton R, Capparelli E, Ellis R | | Year: 2007 | | Publication: Journal of Neuroimmune Pharmacology : The Official Journal of The Society On NeuroImmune Pharmacology | | Volume: 2 Issue: 1 Pages: 97-104 | | Abstract:Abstract Many clinical trials compare one specific treatment
to a control or standard treatment. In HIV therapeutics,
such fixed-regimen designs may be problematic as
individualized treatment regimens are standard practice.
Designing and implementing a trial that allows individualized
treatment options poses particular challenges. In this
example of a clinical trial in NeuroAIDS, it is hypothesized
that some antiretroviral drugs [i.e., those that penetrate the
blood–brain barrier sufficiently to inhibit HIV in the central
nervous system (CNS)] will improve HIV neurocognitive
impairment, whereas non-penetrating antiretrovirals will
not be as effective in improving neurocognitive function.
To test this hypothesis, a uniquely designed strategy trial
was developed that consists of three essential components:
(1) a scoring system that ranks regimens for CNS
penetration based on semiquantitative criteria, (2) committee-
established individualized regimen options that allow
randomization to opposite ends of the CNS penetration
spectrum, and (3) timely implementation across multiple
centers via web-based resources. For the proposed trial, the
three components are combined with an adaptive randomization scheme to minimize potential confounding by
several important factors. A small pilot study demonstrated
the feasibility and acceptability to providers. In conclusion,
an innovative design can provide solutions to challenging
practical issues in trials with multiple treatment options. |
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