Clareo Health | Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide written informed consent
Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
HCV RNA \> 1 x 10\^4 IU/mL at screening
Infection with HCV genotype 1, 2 or 3 as determined at screening
HIV-1 infection confirmed with positive ELISA or Western blot at screening
Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
Confirmation of chronic HCV infection
Ability to determine presence/absence of cirrhosis.
HIV antiretroviral therapy (ARV) criteria of one of the following:
* ARV untreated with a CD4 T-cell count \> 500 cells/mm\^3
* On a stable, protocol-approved, ARV for \> 8 weeks prior to screening with a CD4 T-cell count \> 200 cells/mm\^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
Approved HIV antiretroviral medications based on drug interaction studies
Not been treated with any investigational drug or device within 30 days of the screening visit
Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
Must be of generally good health as determined by the investigator.
Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
You may not be if
Non-genotype 1/2/3 or mixed genotype at screening
Genotype 1 with prior treatment for HCV
Poor control with ARV regimen
Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
A new AIDS-defining condition diagnosed within 30 days prior to screening
Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
Infection with hepatitis B virus (HBV)
Contraindication to RBV therapy
Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day)
History of solid organ transplantation or malignancy diagnosed or treated within 5 years
Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
