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
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ClinicalTrials.gov Identifier: NCT00353418 |
Recruitment Status
:
Completed
First Posted
: July 18, 2006
Results First Posted
: June 15, 2010
Last Update Posted
: August 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: Peginterferon alfa-2a Drug: Ribavirin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 415 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |
Arm | Intervention/treatment |
---|---|
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
|
- Sustained Virological Response (SVR) [ Time Frame: Week 72 ]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 ]Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
- Virological Response at End of Treatment Period [ Time Frame: Week 48 ]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 ]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 ]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 ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353418
Study Director: | Clinical Trials | Hoffmann-La Roche |
Additional Information:
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 |
First Posted: | July 18, 2006 Key Record Dates |
Results First Posted: | June 15, 2010 |
Last Update Posted: | August 3, 2010 |
Last Verified: | July 2010 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |