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

NCT02220868 | Completed Phase 4

• 1 other identifier: IN-US-334-1527
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Infection; HIV Infection

Keywords

HIV; HCV; DAA

Outcome Measures

Primary Outcomes (1)

• • 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

  12 weeks post treatment

Study Arms (1)

Sofossbuvir, Riabvirin, Stribild

OTHER

Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

Drug: Sofosbuvir, Ribavirin, and Stribild

Interventions

Sofosbuvir, Ribavirin, and Stribild DRUG

Sofossbuvir, Riabvirin, Stribild

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Michael's Medical Center: lead

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Interventions

Sofosbuvir; Ribavirin; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jihad Slim, MD

  Saint Michael's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Prgram Director, Infectious Diseases

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2015-11

Locations

US (1)