Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Willing to participate in the study and sign the Informed Consent Form

• Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)

• Can be treatment-naïve, have retreatment, or co-infected with HIV

• Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit

Exclusion Criteria:

• Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form

• Prior treatment with PegIntron (combined with ribavirin or not)

• History of alcohol abuse in the past 6 months

• Decompensated liver disease

• Severe heart disease

• Decompensated thyroid disorder

• Neoplasia

• Type 1 diabetes mellitus - uncontrolled or hardly controlled

• Seizures - uncontrolled

• Primary immune deficiency

• Men and women not using appropriate contraceptive methods

• Pregnancy or lactation

• For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm^3