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Hepatitis C, ChronicPhase 4NCT02206932

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

A Phase 4 study testing Sofosbuvir + Simeprevir in people with Hepatitis C, Chronic and HIV CDC Category A1, run by University of California, San Francisco at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic, HIV CDC Category A1
What is being tested?
Sofosbuvir + Simeprevir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2014to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 49Show fewer
  • 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:
  • 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):
  • CD4 T-cell count >100 cells/mm3 if on ART, ≥ 350 cells/mm3 if not on ART
  • ALT ≤10 x the upper limit of normal (ULN)
  • AST ≤10 x ULN
  • Direct bilirubin ≤1.5 ULN
  • Creatinine clearance (CrClr) ≥50 mL /min, as calculated by the Cockcroft-Gault equation
  • Hemoglobin ≥10 g/dL
  • Albumin ≥3g/dL
  • INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
  • Alpha feto protein (AFP) levels <50. If ≥ 50, they should have a liver imaging study (eg, ultrasound, CT scan, MRI) showing no evidence of hepatocellular carcinoma within 3 months of study enrollment
  • Female subjects of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy) must have a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL performed during screening, within 48 hours prior to study entry.
  • All subjects must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
  • NOTE: Female candidates who are pregnant or breastfeeding are not eligible. A male candidate who has a pregnant female partner is not eligible for the study.
  • When participating in sexual activity that could lead to pregnancy, all subjects must agree to use at least two non-hormonal forms of contraceptive simultaneously while receiving protocol-specified medications, and for 4 weeks after stopping the medications. Such methods include:
  • Condoms (male or female) with or without a spermicidal agent
  • Diaphragm or cervical cap with spermicide
  • Intrauterine device (IUD)
  • Tubal ligation NOTE: Providers and subjects should be advised that not all contraceptive choices listed above can prevent HIV transmission and that some may actually increase the risk of HIV acquisition. Study subjects who are sexually active with HIV-1 negative or unknown HIV-1 serostatus partners should be advised that they need to consider effective strategies for reducing the risk of HIV transmission, as well as meeting the requirement for effective contraception during their participation in the study. Study subjects should discuss contraceptive choices and HIV risk reduction methods with their health care provider.
  • Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy or men who have documented azoospermia or undergone vasectomy) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization and menopause is specified below.
  • Written or oral documentation communicated by clinician or clinician's staff of one of the following:
  • Physician report/letter
  • Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
  • Discharge summary
  • Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory.
  • Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco General Hospital, University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: An Open Label, Pilot Study to Investigate the Safety and Efficacy of 12 Weeks of Simeprevir and Sofosbuvir, for HIV-infected, HCV Genotype 1 Patients With Advanced Fibrosis

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.

Read the detailed description

This is a research study of an investigational combination of two hepatitis C medications call sofosbuvir (SOF) and simeprevir (SMV). Both medications are approved by the U.S. Food and Drug Administration (FDA) for treatment of hepatitis C in combination with other medications. The combination sofosbuvir and simeprevir has not been approved by the FDA and is being tested as an investigational combination in research studies such as this. The purpose of this study is to see if SOF + SMV given for 12 weeks is safe and able to clear the Hepatitis C virus (HCV) from subjects who are co-infected with HIV-1 and who have scarring of the liver (fibrosis of 3 or 4 on a scale of 0-4, with 4 as the most scarring, also known as cirrhosis).

This study is an investigator-initiated clinical trial sponsored by University of California, San Francisco (UCSF), with support and the study drug simeprevir provided by Janssen Scientific Affairs, LLC.

Being tested
Sofosbuvir + Simeprevir
Keywords
Hepatitis C, HIV, Simeprevir, Sofosbuvir
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sofosbuvir + SimeprevirDrug

    Also called Sovaldi, Olysio, TMC435

Study groups in NCT02206932
Study groupRoleWhat they receive
Sofosbuvir + SimeprevirOtherSubjects will be enrolled and treated with simeprevir 150 mg and sofosbuvir 400 mg once daily for 12 weeks
Receives: Drug: Sofosbuvir + Simeprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SVR12 (HCV RNA <LLOQ, or lower limit of quantification)

    Measured: 12 weeks after discontinuation of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study startAug 2014 (estimated)
  3. Primary completionSep 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Why it stopped: never opened

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02206932
Sponsor's protocol ID
TMC435HPC2008
Status last verified
Jun 2019
First submitted
30 Jul 2014
Last updated
13 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • Kirk GD, Mehta SH, Astemborski J, Galai N, Washington J, Higgins Y, Balagopal A, Thomas DL. HIV, age, and the severity of hepatitis C virus-related liver disease: a cohort study. Ann Intern Med. 2013 May 7;158(9):658-66. doi: 10.7326/0003-4819-158-9-201305070-00604.

    PubMed 23440167

  • Sulkowski MS, Mehta SH, Torbenson MS, Higgins Y, Brinkley SC, de Oca RM, Moore RD, Afdhal NH, Thomas DL. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. AIDS. 2007 Oct 18;21(16):2209-16. doi: 10.1097/QAD.0b013e3282f10de9.

    PubMed 18090048

  • Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, Sneller M, Kohli A, Barrett L, Proschan M, Herrmann E, Shivakumar B, Gu W, Kwan R, Teferi G, Talwani R, Silk R, Kotb C, Wroblewski S, Fishbein D, Dewar R, Highbarger H, Zhang X, Kleiner D, Wood BJ, Chavez J, Symonds WT, Subramanian M, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309.

    PubMed 23982366

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sofosbuvir + Simeprevir in people with Hepatitis C, Chronic and HIV CDC Category A1, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 49 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SVR12 (HCV RNA <LLOQ, or lower limit of quantification) (time frame: 12 weeks after discontinuation of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206932, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.

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