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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

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ClinicalTrials.gov Identifier: NCT02220868
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jihad Slim, MD, Saint Michael's Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Infection HIV Infection Drug: Sofosbuvir, Ribavirin, and Stribild Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Study Start Date : July 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
Sofossbuvir, Riabvirin, Stribild
Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild
 Drug: Sofosbuvir, Ribavirin, and Stribild


Outcome Measures
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Primary Outcome Measures :
  1. • 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220868


Locations
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United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Saint Michael's Medical Center
Investigators
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Principal Investigator: Jihad Slim, MD Saint Michael's Medical Center
More Information
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Responsible Party: Jihad Slim, MD, Chief and Prgram Director, Infectious Diseases, Saint Michael's Medical Center
ClinicalTrials.gov Identifier: NCT02220868    
Other Study ID Numbers: IN-US-334-1527
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: November 2015
Keywords provided by Jihad Slim, MD, Saint Michael's Medical Center:
HIV
HCV
DAA
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Sofosbuvir
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents