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.

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 -

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002515-25-ES

Enrollment

Registered

2012-06-22

Start date

2012-09-10

Completion date

Unknown

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV–HCV co-infected patients MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10065949 Term: HCV coinfection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Incivo Product Name: Incivo Product Code: Telaprevir Pharmaceutical Form: Film-coated tablet INN or Proposed INN: It is a NS3-4A protease inhibitor reduces the amount of hepatitis C virus

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Spain

Contacts

Public ContactClara M. Rosso Fernández

Unidad de Investigación Clínica y Ensayos Clínicos. Hospital Universitario Virgen del Rocío

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026