Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir
This study has been completed.
Sponsor:
Hospitales Universitarios Virgen del Rocío
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01818856
First received: December 29, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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-co-infected patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic HIV Infection |
Drug: Ritonavir withdrawal, atazanavir 200 mg/12h Drug: Telaprevir interactions |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir in HIV/HCV-co-infected Patients Under Treatment for Genotype 1 Chronic Hepatitis C. |
Resource links provided by NLM:
Further study details as provided by Hospitales Universitarios Virgen del Rocío:
Primary Outcome Measures:
- Changes in pharmacokinetic parameters of TVR [ Time Frame: 7 - 10 days ] [ Designated as safety issue: No ]The Telaprevir peak concentrations (Cmax), trough levels (Cmin) at 8 or 12 hours, the areas under the curves over the dosing interval (AUC0-τ), and half-life during the elimination phase (t½ β) will be compared between days 0 and 7 as geometric mean ratios (GMRs) and their 90% CIs using day 0 values as reference. The differences in pharmacokinetic parameters between the regimens will be considered significant when the interval between low and high 90% CI did not include the value 1.0.
Secondary Outcome Measures:
- Changes in pharmacokinetic parameters of ATV [ Time Frame: 7 - 10 days ] [ Designated as safety issue: No ]The Atazanavir peak concentrations (Cmax), trough levels (Cmin) at 12 or 24 hours, the areas under the curves over the dosing interval (AUC0-τ), and half-life during the elimination phase (t½ β) will be summarized as geometric means (GM) and will be compared between days 0 and 7 as geometric mean ratios (GMRs) and their 90% CIs using day 0 values as reference. The differences in pharmacokinetic parameters between the regimens will be considered significant when the interval between low and high 90% CI did not include the value 1.0.
| Estimated Enrollment: | 14 |
| Study Start Date: | December 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Telaprevir interactions
Telaprevir 750 mg/8h or 1125 mg/12h (+ pegIFN alfa and ribavirin) plus Atazanavir/ritonavir 300/100 mg/24. Pharmacokinetic profile on day 0. Intervention: Ritonavir will be withdrawn and the atazanavir dose increased to 200 mg/12h for days 1 to 7. On day 8: a morning dose of Telaprevir (750 mg or 1125 mg) plus Atazanavir 200 mg. Pharmacokinetic profile for 12 hours |
Drug: Ritonavir withdrawal, atazanavir 200 mg/12h
Other Names:
Drug: Telaprevir interactions
Other Names:
|
Detailed Description:
Objectives
- 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-boosted Atazanavir (200 mg/12h), taking as reference the pharmacokinetic parameters observed when TVR is administered with Atazanavir/ritonavir (300/100 mg/day)
- To assess the changes in the plasma pharmacokinetic parameters of Atazanavir administered as 200 mg/12h with respect to its administration as 300/100 mg/day when administered together with TVR (750 mg/8h or 1125 mh/12h).
Method: open labelled clinical trial with a planned duration of 24 weeks in which 14 HIV/Hepatitis C virus genotype 1 patients under treatment with pegylated α-interferon, Ribavirin and Telaprevir will be enrolled. A 24 hours pharmacokinetic profile will be obtained after a supervised drug intake while taking TVR and ATV/rtv. Afterwards, the patients will take un-boosted ATV 200 mg bid for 7 - 10 days. Subsequently, a new pharmacokinetic profile will be obtained.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01818856
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818856
Locations
| Spain | |
| Hospital Universitario Virgen del Rocio | |
| Seville, Spain, 41013 | |
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Luis F Lopez-Cortes, MD, PhD. | Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla. Spain. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Luis F. Lopez-Cortes, MD, PhD, Hospitales Universitarios Virgen del Rocío |
| ClinicalTrials.gov Identifier: | NCT01818856 History of Changes |
| Other Study ID Numbers: | LLC-TEL-2012-1 2012-002515-25 |
| Study First Received: | December 29, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospitales Universitarios Virgen del Rocío:
|
Chronic hepatitis C HIV-infection Drug interaction |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis Hepatitis A HIV Infections Hepatitis C, Chronic Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Liver Diseases Digestive System Diseases Enterovirus Infections Picornaviridae Infections Lentivirus Infections Retroviridae Infections |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepatitis, Chronic Ritonavir Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016