Hepatitis C Infection, HIV Infection
Conditions
Keywords
HIV, HCV, DAA
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-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
Interventions
DRUGSofosbuvir, Ribavirin, and Stribild
Sponsors
Saint Michael's Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy | 12 weeks post treatment | patients who have achieved non-detectable HCV levels 12 weeks post treatment |
Countries
United States
Outcome results
None listed