Study about pharmacokinetic interactions between Telaprevir and Atazanavir in co-infected patients with HIV and hepatitis C wiht chronic liver disease due to hepatitis C.

• Conditions: HIV–HCV co-infected patients; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10065949Term: HCV coinfectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-002515-25-ES
• Lead Sponsor: uis López Cortes - FISEVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-22
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. HIV–HCV co-infected patients over 18 years old under treatment with Pegylated Interferon, Ribavirine and Telaprevir according to the advices of Agencia Española del Medicamento y Productos Sanitarios.

2. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The usual exclusion criteria in clinical practice to start treatment with these drugs (Pegylated interferon, Ribavirine, Telaprevir and Atazanavir) according to national and international recommendations.

2. Concomitant medication or medicinal products that can interfere the pharmacokinetics of Telaprevir or Atazanavir.

3. Medical history of bad absorption or diarrhea (>3 stools) that could alter the absorption of these drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess changes in plasma pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered, taking as reference the observed pharmacokinetic parameters when given with Atazanavir/ritonavir 300/ 100 mg per day or Raltegravir.;Secondary Objective: To assess changes in plasma pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day and if the concentrations achieved with this dose are suitable when administered together with Telaprevir 750 mg/8h;Primary end point(s): To assess changes pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered.;Timepoint(s) of evaluation of this end point: Blood samples will be taken before Telaprevir and antiretroviral therapy and 1,2,3,4,6,7,8,10 and 12 hours after the dose of Telaprevir and antiretroviral therapy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day.;Timepoint(s) of evaluation of this end point: Between 7-10 days after the change of treatment, blood samples will be taken before and after 1, 2, 3, 5, 6, 7, 8, 10, 12 hours after the dose of Telaprevir and Atazanavir.