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
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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 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:
|
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013