Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
NCT ID: NCT02761629
Last Updated: 2016-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2005-04-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Peg-Interferon Alpha-2A
Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
Ribavirin
Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Peg-Interferon Alpha-2A
Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
Ribavirin
Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
Interventions
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Peg-Interferon Alpha-2A
Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
Ribavirin
Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Campinas, , Brazil
Florianópolis, , Brazil
Itajaí, , Brazil
Juiz de Fora, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro, , Brazil
Rio Grande, , Brazil
Santo André, , Brazil
Santos, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Countries
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Other Identifiers
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ML18473
Identifier Type: -
Identifier Source: org_study_id
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