A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353418
First received: July 17, 2006
Last updated: July 30, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: Peginterferon alfa-2a Drug: Ribavirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Sustained Virological Response (SVR) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
- Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia [ Time Frame: Up to Week 72 ] [ Designated as safety issue: Yes ]Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
Secondary Outcome Measures:
- Virological Response at End of Treatment Period [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
- Virological Response at Weeks 4, 12 and 24 [ Time Frame: Weeks 4, 12 and 24 ] [ Designated as safety issue: No ]Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
- Relapse of Virological Response [ Time Frame: Weeks 48 and 72 ] [ Designated as safety issue: No ]Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
- Rapid Virological Response (RVR) by Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
- Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.
| Enrollment: | 415 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg |
Drug: Peginterferon alfa-2a
180 µg subcutaneously weekly for 48 weeks
Other Name: Pegasys
Drug: Ribavirin
800 mg orally daily for 48 weeks
Other Name: Copegus
|
| Active Comparator: PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg |
Drug: Peginterferon alfa-2a
180 µg subcutaneously weekly for 48 weeks
Other Name: Pegasys
Drug: Ribavirin
1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
Other Name: Copegus
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, ≥18 years of age
- CHC genotype 1
- Stable HIV-1 infection
Exclusion Criteria:
- Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
- Medical condition associated with liver disease other than CHC infection
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353418
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353418
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Additional Information:
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00353418 History of Changes |
| Other Study ID Numbers: | NV18209 |
| Study First Received: | July 17, 2006 |
| Results First Received: | May 14, 2010 |
| Last Updated: | July 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Digestive System Diseases Enterovirus Infections Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections |
RNA Virus Infections Virus Diseases Peginterferon alfa-2a Ribavirin Anti-Infective Agents Antimetabolites Antiviral Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015