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
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