HIV Infections Clinical Trial
Official title:
Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation
The purpose of this study is to see how treatment of hepatitis C (HCV) patients with
ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV).
Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little
information about the way these drugs interact in the body. This study will examine how the
drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV
therapy.
RBV, a nucleoside analogue, is used for the treatment of hepatitis C virus (HCV) in alliance
with interferon-alfa 2a/2b in patients with HIV-1. The mechanism of action of RBV has led to
in vitro studies examining the agonism/antagonism in efficacy occurring when used in
combination with nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective
of the pharmacology component of this current study will be the evaluation of the effect of
RBV on the intracellular activation of ZDV or d4T owing to the reported antagonism observed
in vitro.
Pharmacokinetic (PK) evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and
measurements of their triphosphate anabolites are performed before initial RBV dosing
(within 2 weeks of visit) and 8 weeks after RBV administration. Thymidine triphosphate (TTP)
concentrations also are quantitated to permit estimation of the ratio of active drug to
endogenous triphosphate concentrations.
For entry, prior to RBV dosing, blood samples are collected within 2 hours prior to the ZDV
or d4T dose and then at Hours 1, 4, and 8 post dosing. Following the entry PK blood draws,
patients initiate RBV treatment within 2 weeks of the first PK study day.
For the Week 8 evaluation (measured as 8 weeks following initiation of RBV), blood samples
are collected prior to the ZDV or d4T dose and then at Hours 1, 4, and 8 post dosing.
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