Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Saint Michael's Medical Center


Information provided by (Responsible Party)
Jihad Slim, MD, Saint Michael's Medical Center

ClinicalTrials.gov Identifier
NCT02220868

First received: August 18, 2014
Last updated: August 3, 2016
Last Verified: November 2015
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Hepatitis C Infection
HIV Infection

Drug : Sofosbuvir, Ribavirin, and Stribild
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Jihad Slim, MD, Saint Michael's Medical Center:

Primary Outcome Measures

  • • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy [ Time Frame: 12 weeks post treatment ]
    patients who have achieved non-detectable HCV levels 12 weeks post treatment

Enrollment: 10
Study Start Date: July 2014
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Sofossbuvir, Riabvirin, Stribild
Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild
Drug: Sofosbuvir, Ribavirin, and 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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02220868

Locations

United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102

Sponsors and Collaborators

Saint Michael's Medical Center

Investigators

Principal Investigator: Jihad Slim, MD Saint Michael's Medical Center
More Information

More Information


Responsible Party: Jihad Slim, MD, Chief and Prgram Director, Infectious Diseases, Saint Michael's Medical Center  
ClinicalTrials.gov Identifier: NCT02220868   History of Changes  
Other Study ID Numbers: IN-US-334-1527  
Study First Received: August 18, 2014  
Last Updated: August 3, 2016  

Keywords provided by Jihad Slim, MD, Saint Michael's Medical Center:

HIV
HCV
DAA

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis, Chronic
Hepatitis C, Chronic
Ribavirin
Tenofovir
Emtricitabine
Sofosbuvir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.