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Clinical Trials/EUCTR2012-002515-25-ES
EUCTR2012-002515-25-ESActive, not recruitingNot Applicable

Pharmacokinetic interactions between Telaprevir and not powered Atazanavir with ritonavir in co-infected patients with HIV and HCV genotype 1 in treatment for chronic liver disease by HCV

uis López Cortes - FISEVI0 sites12 target enrollmentStarted: June 22, 2012Last updated:
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
12

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

Sponsor
uis López Cortes - FISEVI

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