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

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

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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 |
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

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
United States, New Jersey | |
Saint Michael's Medical Center | |
Newark, New Jersey, United States, 07102 |
Principal Investigator: | Jihad Slim, MD | Saint Michael's Medical Center |
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 |
HIV HCV DAA |
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 |