Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\>=18 and \<=65 years of age
Body weight \>=40 and \<=125 kg
Documented history of HIV infection for greater than 6 months prior to Day 1
On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 \>=200 cells/µL and HIV-1 RNA viral load \<50 copies/mL
Documented chronic hepatitis C (CHC) genotype 1 infection (greater than 6 months prior to Day 1)
Use of acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months or longer after treatment
Liver biopsy with histology consistent with CHC and no other etiology
You may not be if
Participants who received prior treatment for hepatitis C other than herbal remedies except those with known hepatotoxicity
Coinfected with hepatitis B virus (Hepatitis B surface antigen (HBsAg) positive) and/or demonstrating signs and symptoms consistent with concomitant infection
Evidence of decompensated liver disease
Participants who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 or had first initiated anti-retroviral therapy within the last 6 months prior to Day 1
Use of certain HIV medications will not be allowed. Medications will be reviewed by the Investigator
History of clinically significant opportunistic infections (except oral thrush) within the last year prior to Day 1
Current evidence of substance abuse within 3 years of the Screening Visit
History of a clinical diagnosis within the past 6 months of substance abuse prior to Day 1
Participants receiving opiate agonist substitution therapy but not enrolled in an opiate substitution maintenance program
History of marijuana use deemed excessive by the Investigator
Infected with HIV-2
Use of any HIV protease inhibitor without the coadministration of ritonavir within one month of Day 1 and throughout the period of the trial
Participants receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam.
Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements):
* Hemoglobin \<11 g/dL for females and \<12 g/dL for males
* Direct bilirubin \>1.5 x ULN (upper limit of normal) of the laboratory reference range. Total bilirubin \>1.6 mg/dL unless history of Gilbert's disease or antiretroviral regimen contains atazanavir. If Gilbert's disease is the proposed etiology, this must be documented in the participant's chart
Alpha fetoprotein (AFP):
* AFP \>100 ng/mL OR
* AFP 50 to 100 ng/mL (requires a liver ultrasound and participants with findings suspicious for hepatocellular carcinoma are excluded)
