Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01500616
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2011-12-22
Brief Title:
Telaprevir Open-Label Study in Co-Infected Patients
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
Multicenter Open-Label Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency VirusGenotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIVgenotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir
Detailed Description:
In this study all patients will receive open-label all people involved know the identity of the intervention telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C virus HCV and protocol permissible treatments for HIV Chronic hepatitis C infection causes inflammation of the liver which can potentially cause long-term complications of the current liver disease fibrosis or cirrhosis Therefore it is important the patient is treated for this infection Telaprevir is an experimental medication that has been tested for the treatment of hepatitis C infections in several previous studies in more than 2500 patients Telaprevir is a member of a new class of drugs being developed for chronic hepatitis C Direct Acting Antiviral DAA agents Unlike pegylated interferon Peg-IFN and ribavirin RBV DAA agents act directly on the hepatitis C virus HCV replication cycle The aim of the telaprevir treatment is to eradicate the Hepatitis C virus out of the patients body This can be measured by testing the amount of a certain part of this Hepatitis C virus called the Ribonucleic acid RNA HCV RNA in their blood It is possible that the patient will not respond to the therapy and the levels of HCV RNA in their blood will not decrease or even increase Based on these results it might be decided the patient will not benefit from treatment and heshe need to stop the telaprevir only or all medication for their hepatitis C infection The doctor will keep them informed about the patients reaction to the treatment and will take the necessary measurements as prescribed by the study protocol and routine medical practice During the study the patient will simultaneously be treated with the therapy that the doctor would normally prescribe for treatment of their chronic hepatitis C infection ribavirin RBV and pegylated interferon alfa PEG-INF-alfa Telaprevir is always administered in combination with RBV and PEG-IFN-alfa In function of the patients specific HIV status the doctor has prescribed or not a specific treatment that the patient will continue to take during the study This treatment could be a efavirenz tenofovir disoproxil fumarate TDF plus either emtricitabine or lamivudine b efavirenz abacavir plus either emtricitabine or lamivudine c ritonavir-boosted atazanavir TDF plus either emtricitabine or lamivudine d ritonavir-boosted atazanavir abacavir plus either emtricitabine or lamivudine e raltegravir TDF plus either emtricitabine or lamivudine f raltegravir abacavir plus either emtricitabine or lamivudine or g etravirine TDF plus either emtricitabine or lamivudin h etravirine abacavir plus either emtricitabine or lamivudine i rilpivirine TDF plus either emtricitabine or lamivudine j rilpivirine abacavir plus either emtricitabine or lamivudine k no treatment In an interim analysis of a Phase 2a study human immunodeficiency virus HIV-1HCV genotype 1 coinfected patients currently receiving HIV therapy who had telaprevir added to Peg IFN-alfa-2a and RBV regimen for treatment of their HCV genotype 1 infection had a higher HCV RNA response undetectable HCV RNA at Weeks 4 and 12 than those who received only the Peg-IFN-alfa-2a and RBV regimen These responses were sustained through Week 24 with 737 of patients who had telaprevir added to the Peg-IFN-alfa-2a and RBV regimen and 545 of patients who received only the Peg-IFN-alfa-2a and RBV regimen also achieving undetectable HCV RNA at Week 24 Patients with severe fibrosis or cirrhosis have a lower likelihood of sustained virologic response SVR and also have the greatest risk of liver failure hepatocellular carcinoma HCC and death Administering telaprevir in this difficult to treat population may reduce the risk of long-term complications associated with HCV in patients with HIVHCV genotype 1 coinfection All patients eligible to enter the study will receive telaprevir 750 or 1125 mg every 8 hours based on their Highly Active Antiretroviral Therapy HAART regimen during the first 12 weeks of the study in combination with Peg IFN alfaRBV Patients will subsequently be treated with Peg-IFN-alfaRBV for an additional 36 weeks The total duration of Peg-IFN-alfaRBV will be 48 weeks HCV RNA levels should be measured at Weeks 4 12 24 and 48 All patients should have a posttreatment follow-up visit including measurement of plasma HCV RNA levels performed 24 weeks after the last administered dose of treatment Note that in certain countries an additional main objective of the study is to provide Early Access to telaprevir in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VX-950HPC3005 | OTHER | None | None |
| 2011-003593-85 | EUDRACT_NUMBER | Janssen-Cilag International NV | None |