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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

Primary Purpose

Hepatitis C Infection, HIV Infection

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sofosbuvir, Ribavirin, and Stribild

About this trial

This is an interventional treatment trial for Hepatitis C Infection focused on measuring HIV, HCV, DAA

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Saint Michael's Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sofossbuvir, Riabvirin, Stribild

Arm Description

Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

Outcomes

Primary Outcome Measures

• 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

Secondary Outcome Measures

Full Information

NCT ID

NCT02220868

First Posted

August 18, 2014

Last Updated

August 3, 2016

Sponsor

Saint Michael's Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02220868

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saint Michael's Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Infection, HIV Infection

Keywords

HIV, HCV, DAA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sofossbuvir, Riabvirin, Stribild

Arm Type

Other

Arm Description

Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir, Ribavirin, and Stribild

Primary Outcome Measure Information:

Title

• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy

Description

patients who have achieved non-detectable HCV levels 12 weeks post treatment

Time Frame

12 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jihad Slim, MD

Organizational Affiliation

Saint Michael's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Michael's Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

12. IPD Sharing Statement

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