HIV Infection Clinical Trial
Official title:
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir in HIV/HCV-co-infected Patients Under Treatment for Genotype 1 Chronic Hepatitis C.
Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues (NRTIs) in HCV/HIV-co-infected patients.
Objectives
1. Primary Outcome Measures: evaluate the changes in the plasma pharmacokinetic parameters
(Cmax, Cmin, AUC, t 1/2, and Cl) of Telaprevir (TVR) administered at 750 mg/8h together
with un-boosted Atazanavir (200 mg/12h), taking as reference the pharmacokinetic
parameters observed when TVR is administered with Atazanavir/ritonavir (300/100 mg/day)
2. To assess the changes in the plasma pharmacokinetic parameters of Atazanavir
administered as 200 mg/12h with respect to its administration as 300/100 mg/day when
administered together with TVR (750 mg/8h or 1125 mh/12h).
Method: open labelled clinical trial with a planned duration of 24 weeks in which 14
HIV/Hepatitis C virus genotype 1 patients under treatment with pegylated α-interferon,
Ribavirin and Telaprevir will be enrolled. A 24 hours pharmacokinetic profile will be
obtained after a supervised drug intake while taking TVR and ATV/rtv. Afterwards, the
patients will take un-boosted ATV 200 mg bid for 7 - 10 days. Subsequently, a new
pharmacokinetic profile will be obtained.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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