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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220868
• Other study ID #: IN-US-334-1527
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2014
• Last updated: August 3, 2016
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Saint Michael's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• Sofosbuvir, Ribavirin, and Stribild

Locations

Country	Name	City	State
United States	Saint Michael's Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Saint Michael's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy	patients who have achieved non-detectable HCV levels 12 weeks post treatment	12 weeks post treatment	No