A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
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Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
