Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir

NCT01818856 | Completed Phase 1 DMC

• 2 other identifiers: LLC-TEL-2012-12012-002515-25
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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-co-infected patients.

Conditions

Hepatitis C, Chronic; HIV Infection

Keywords

Chronic hepatitis C; HIV-infection; Drug interaction

Outcome Measures

Primary Outcomes (1)

• Changes in pharmacokinetic parameters of TVR

  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.

  7 - 10 days

Secondary Outcomes (1)

• Changes in pharmacokinetic parameters of ATV

  7 - 10 days

Study Arms (1)

Telaprevir interactions

EXPERIMENTAL

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 Intervention: Ritonavir will be withdrawn and the atazanavir dose increased to 200 mg/12h for days 1 to 7.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; Drug: Telaprevir interactions

Interventions

Ritonavir withdrawal, atazanavir 200 mg/12h DRUG

Also known as: Reyataz, Norvir, Incivo

Telaprevir interactions

Telaprevir interactions DRUG

Also known as: Incivo, Reyataz, Norvir

Telaprevir interactions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (2)

• Gutierrez-Valencia A, Ruiz-Valderas R, Ben-Marzouk-Hidalgo OJ, Torres-Cornejo A, Espinosa N, Castillo-Ferrando JR, Viciana P, Lopez-Cortes LF. Telaprevir and ribavirin interaction: higher ribavirin levels are not only due to renal dysfunction during triple therapy. Antimicrob Agents Chemother. 2015;59(6):3257-62. doi: 10.1128/AAC.04795-14. Epub 2015 Mar 23.

  PMID: 25801562 DERIVED

• Gutierrez-Valencia A, Ruiz-Valderas R, Torres-Cornejo A, Viciana P, Espinosa N, Castillo-Ferrando JR, Lopez-Cortes LF. Role of ritonavir in the drug interactions between telaprevir and ritonavir-boosted atazanavir. Clin Infect Dis. 2014 Jan;58(2):268-73. doi: 10.1093/cid/cit693. Epub 2013 Oct 21.

  PMID: 24145880 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Luis F Lopez-Cortes, MD, PhD.

  Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla. Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: March 27, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

ES (1)