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Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir

Information source: Hospitales Universitarios Virgen del Roco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; HIV Infection

Intervention: Ritonavir withdrawal, atazanavir 200 mg/12h (Drug); Telaprevir interactions (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hospitales Universitarios Virgen del Roco

Official(s) and/or principal investigator(s):
Luis F Lopez-Cortes, MD, PhD., Principal Investigator, Affiliation: Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla. Spain.

Summary

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.

Clinical Details

Official title: Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir in HIV/HCV-co-infected Patients Under Treatment for Genotype 1 Chronic Hepatitis C.

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in pharmacokinetic parameters of TVR

Secondary outcome: Changes in pharmacokinetic parameters of ATV

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients over 18 years old co-infected with HIV and genotype 1 HCV under treatment

with pegylated α-interferon, Ribavirin and Telaprevir according to the recommendations of the Spanish Agency of Medicines and Health Products.

- Informed consent of the patient.

Exclusion Criteria:

- The usual exclusion criteria in clinical practice to start the treatment with these

drugs (pegylated α-interferon, Ribavirin, Telaprevir and atazanavir) according to the Spanish and international recommendations (Spanish Agency of Medicines and Health Products,European Association for the Study of the Liver Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011. Consensus Document of Gesida/Spanish Plan on Aids regarding the antiretroviral treatment in adults infected with the human immunodeficiency virus [Updated January 2012]).

- Concomitant use of drugs or medicinal products that could alter the pharmacokinetics

of TVR or ATV.

- Medical records suggesting malabsorption or presence of diarrhea (>3 depositions/day)

that could interfere with the absorption of the studied drugs.

Locations and Contacts

Hospital Universitario Virgen del Rocio, Seville 41013, Spain
Additional Information

Starting date: December 2012
Last updated: April 19, 2013

Page last updated: August 23, 2015

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