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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353418
• Other study ID #: NV18209
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2006
• Last updated: July 30, 2010
• Start date: June 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections

Intervention

Drug:
• Peginterferon alfa-2a
180 µg subcutaneously weekly for 48 weeks
• Ribavirin
800 mg orally daily for 48 weeks
• Ribavirin
1000 mg or 1200 mg (based on patient weight of < 75 kg or = 75 kg, respectively) orally daily for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response (SVR)	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.	Week 72	No
Primary	Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia	Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.	Up to Week 72	Yes
Secondary	Virological Response at End of Treatment Period	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.	Week 48	No
Secondary	Virological Response at 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.	Weeks 4, 12 and 24	No
Secondary	Relapse of Virological Response	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.	Weeks 48 and 72	No
Secondary	Rapid Virological Response (RVR) by 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.	Week 4	No
Secondary	Early Virological Response (EVR), Partial EVR and Complete EVR by 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.	Week 12	No

External Links

•   Clinical Study Report Synopsis