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NCT Number: NCT02220868

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

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

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infection HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir, Ribavirin, and Stribild

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint Michael's Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2014
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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