Status:
COMPLETED
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
Lead Sponsor:
Saint Michael's Medical Center
Conditions:
Hepatitis C Infection
HIV Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.
Detailed Description
The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02220868
Start Date
July 1 2014
End Date
September 1 2015
Last Update
August 4 2016
Active Locations (1)
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1
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102