Clinical trial NCT02761629: Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
Official title: Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy and Safety of Combined Peg-Interferon Alpha-2a (40 kD) With Ribavirin Combined Therapy for 48 or 72 Weeks of Treatment and 24 Weeks of Follow-Up in Patients With Chronic Hepatitis C, Genotype 1, Co-Infected With Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).


Eligibility criteria: Inclusion Criteria:

* Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV) test
* Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (\<50 International Units per milliliter \[IU/mL\]) (qualitative test)
* Chronic liver disease consistent with infection of CHC
* Compensated liver disease (Child-Pugh Grade A)
* Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection
* Negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment

Exclusion Criteria:

* Pregnant or nursing women and male partners of pregnant women
* Prior therapy with interferon (IFN) or ribavirin and any investigational medication less than or equal to (\</=) 6 weeks before the first dose of the study drug
* History or other evidence of a medical condition associated with chronic liver disease further than HCV
* Active opportunistic infection associated with HIV and / or cancer requiring systemic therapy
* History of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the Protocol requirements

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR)
timeFrame: 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
Secondary outcomes:
measure: Percentage of Participants With Undetectable HCV RNA
timeFrame: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, and 48; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, and 72
measure: Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A
timeFrame: 12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 84 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
measure: Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment
timeFrame: 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
measure: Serum Human Immunodeficiency Virus (HIV) RNA Levels
timeFrame: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96
measure: Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
timeFrame: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96
measure: Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
timeFrame: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96
measure: Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
timeFrame: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96
Other outcomes:
Locations:
city: Campinas
country: Brazil
city: Florianopolis
country: Brazil
city: Itajaí
country: Brazil
city: Juiz de Fora
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio Grande
country: Brazil
city: Santo Andre
country: Brazil
city: Santos
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: