Status:
COMPLETED
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hepatitis C, Chronic
HIV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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-c...
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-b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01818856
Start Date
December 1 2012
End Date
April 1 2013
Last Update
April 22 2013
Active Locations (1)
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1
Hospital Universitario Virgen del Rocio
Seville, Seville, Spain, 41013