A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C

Withdrawn before enrolling · Phase 4

Conditions studied: Hepatitis C, Chronic, HIV CDC Category A1

In brief

This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.

Key facts

Study ID

NCT02206932

Run by

University of California, San Francisco

People needed

0

Starts

2014-08-01

Expected to finish

2015-12-01

Last updated by the study team

2019-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent
• Male or female, age ≥ 18 years
• Body mass index (BMI) ≥ 18 kg/m2
• HCV RNA ≥ 104 IU/mL at Screening
• HCV genotype 1 at screening or with prior documentation. Any non-definitive genotype results will exclude the subject from study participation
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• Fibrosis determination: Fibrosis of Metavir F3/F4 may be established by one of the following:
• Liver biopsy at any point in time with Metavir score F3/F4, or equivalent on an alternative scale.
• Fibroscan ≥ 9.5 kPA
• FibroSURE: ≥ 0.58
• Liver imaging within 12 months prior to Baseline/Day 1 is required in subjects with known cirrhosis to exclude hepatocellular carcinoma (HCC). Acceptable liver imaging includes ultrasound, CT scan or MRI.
• HCV treatment status of one of the following:
• HCV Treatment-Naive: No prior exposure to any IFN, RBV, or other approved or experimental HCV-specific DAA agents
• HCV Treatment-Experienced: Virologic failure after treatment with PEG-IFN+RBVor standard IFN +RBV. Prior exposure to HCV polymerase or protease inhibitors is exclusionary. Prior treatment experienced patients will be categorized as one of the following:
• i. HCV Treatment-Intolerant: Subjects that discontinued HCV treatment due to development or significant worsening of a treatment related adverse event ii. Null responder: HCV RNA < 2 log10 decline during first 12 weeks of treatment iii. Partial responder: HCV RNA ≥ 2 log10 decline during first 12 weeks of treatment but stopped therapy due to inadequate virologic response iv. Relapse : Undetectable HCV RNA (HCV RNA <LLOQ) on treatment, but experienced breakthrough or relapse
• HIV-1 infection as documented by HIV-1 antibody at screening or any time prior to screening
• HIV treatment status: For subject receiving ART, HIV RNA must be < 40 copies/ml at screening and <200 copies/ml for at least 12 weeks prior to screening. Changes in therapy during the 12 weeks prior to enrollment permitted as long as not due to HIV treatment failure.
• HIV ART allowed in this study are the following and should be administered per the prescribing information in the package insert:
• NRTIs: emtricitabine, lamivudine, tenofovir, abacavir
• Maraviroc
• Integrase inhibitors: dolutegravir or raltegravir
• NNRTI's: rilpivirine
• Enfuvitide Fixed dose combinations are permitted.
• Screening ECG without clinically significant abnormalities
• Subjects must have the following laboratory parameters at Screening and at Pre-entry (if pre-entry visit is required):

You may not qualify if…

• Hepatic decompensation at any point in time (includes variceal bleeding, hepatic encephalopathy, and ascites)
• HBs Ag +
• Prior HCV treatment with an HCV protease inhibitor or HCV polymerase inhibitor including sofosbuvir
• Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency.
• Serious illness including malignancy within 24 weeks prior to study entry, or other chronic medical conditions that in the opinion of the site investigator may preclude completion of the protocol.
• Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry.
• Use of any prohibited concomitant medications
• Child-Pugh Score 6.2.2 Pre-entry>6

Where it is running

• San Francisco General Hospital, University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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