Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.


Options:
A: Inclusion Criteria:

* Participants with documented chronic hepatitis C infection as evidenced by presence of HCV antibody at least 6 months (180 days) prior to the informed consent. - Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level of ≥ 5.0 log10 IU/mL at screening.

Exclusion Criteria:

* Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with any other liver disease than hepatitis C. - Participants with infection/co-infection with non-genotype 1 HCV.
B: Inclusion Criteria:

* Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level \>= 1000 IU/mL
* Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
* Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

* Patient is a previous non-responder that is classified as a viral breakthrough case
* Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
* Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
* Evidence of decompensated liver disease
* Patient has condition that requires use of systemic corticosteroids
C: Inclusion Criteria:

* Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
* HCV RNA \> 10,000 IU/mL at screening
* HCV treatment history:

  * Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
  * Treatment-experienced for HCV genotypes 2 or 3
* HIV antiretroviral (ARV) criteria:

  * On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for \> 8 weeks prior to screening, or
  * ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count \> 500 cells/mm\^3
* Presence or absence of cirrhosis; a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

* HCV genotype 1 or 4 with previous HCV treatment
* Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
* A new AIDS-defining condition diagnosed within 30 days prior to screening
* Prior use of any other inhibitor of the HCV NS5B polymerase
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* Chronic hepatitis B virus (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
* Clinically relevant drug or alcohol abuse within 12 months of screening
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
D: Inclusion Criteria

* Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Male and female subjects, 18 to 70 years of age, inclusive
* Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
* Screening laboratory values, tests, and physical exam within acceptable ranges
* Able and willing to follow contraception requirements
* Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions

Exclusion Criteria

* Subject has any contraindications to Pegasys® or Copegus® therapy
* Evidence of hepatic decompensation in cirrhotic subjects
* History of organ transplant
* History of, or any current medical condition which could impact the safety of the subject in participation in the study

Answer: B