Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

Completed · Phase 4

Conditions studied: Hepatitis C Infection, HIV Infection

In brief

The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

Key facts

Study ID

NCT02220868

Run by

Saint Michael's Medical Center

People needed

10

Starts

2014-07-01

Expected to finish

2015-09-01

Last updated by the study team

2016-08-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Chronic HCV genotype 1 infection
• Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
• CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks
• HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous 12 weeks

You may not qualify if…

• History of integrase inhibitor resistance
• History of integrase inhibitor failure
• Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3
• Patients with cirrhosis
• Platelet count under 90,000 per cubic millimeter
• Hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
• Previous treatment with a DAA
• Hepatocellular carcinoma
• AFP>100 ng/mL
• hepatitis B virus (HBsAg positive)
• Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy

Where it is running

• Saint Michael's Medical Center — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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