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Hepatitis CPhase 2NCT01878799

Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

A Phase 2 study testing GS-7977/GS- 5885 FDC in people with Hepatitis C and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, HIV
What is being tested?
GS-7977/GS- 5885 FDC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jun 2013to Sep 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Eighteen years of age or older at screening.
  • HCV treatment-naive, as defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV-specific direct-acting antiviral agent.
  • Participants must be willing to practice either:
  • Abstinence from sexual intercourse or
  • At least 2 forms of contraception including one barrier method from 2 weeks prior to Day 0 through 30 days after the last dose is received.
  • Female partners of male study subjects may rely upon hormonal contraception as one of the 2 methods; however female study subjects may not.
Show all 26Show fewer
  • Chronic hepatitis C infection defined as one of the following:
  • Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening or
  • Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis).
  • HIV treatment status:
  • Documented HIV infection, ARV untreated for > 8 weeks preceding dosing and having either:
  • a CD4 T-cell count greater than or equal to 500 cells/mm3 within 8 weeks of Day 0 or
  • an HIV viral load less than 500 copies/mL with a stable CD4 count for at least 3 months.
  • Documented HIV infection on a stable, protocol-approved, ARV regimen for greater than or equal to 8 weeks prior to dosing and is expected to continue the current ARV regimen through the end of study with all of the following:
  • a CD4 T-cell count > 100 cells/mm3
  • a documented plasma HIV-1 RNA level less than the level of detection for at least 8 weeks preceding dosing.
  • If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (e.g.,< 20 copies/mL), the Screening plasma HIV-1 RNA level cannot exceed 50 copies/mL.
  • HIV ARV agents including only combination regimens consisting of medications from the following list: tenofovir (TDF), emtricitabine (FTC), efavirenz, raltegravir, and rilpivirine administered according to their manufacturer s prescribing information. (reference Section 10.3 for additional information)
  • Documentation of hepatitis C genotype 1a, 1b or mixed 1a/1b
  • Absence of cirrhosis, defined as one of the following:
  • A liver biopsy performed within 36 calendar months of screening showing absence of cirrhosis.
  • FibroTest score of < 0.48 AND APRI of < 1 performed during the 8 weeks preceding dosing (In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy is required).
  • Able to effectively communicate with the Investigator and other center personnel.
  • Willing to give written informed consent and comply with the study restrictions and requirements.
  • If opioid-dependent, subjects must be participating in a supervised treatment.
  • Participants must have a primary medical provider outside of OP8 and the NIH for medical management.

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Current or prior history of any of the following:
  • Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
  • Poor venous access interfering with required study blood collection.
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
Show all 40Show fewer
  • Solid organ transplantation.
  • Significant pulmonary disease, significant cardiac disease or porphyria.
  • Unstable psychiatric disease (Subjects with psychiatric illness that is well-controlled on a stable treatment regimen or currently not requiring medication may be included).
  • Any malignancy or its treatment that in the opinion of the PI may cause ongoing interference with host immunity; subjects under evaluation for malignancy are not eligible.
  • Significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).
  • Patients with renal impairment or uncontrolled medical problems that could place them at high risk for developing renal impairment.
  • Positive test at screening for either HBsAg or quantifiable HBV DNA (completed only if necessary to rule out chronic HBV)
  • Current use of non-protocol approved ARVs.
  • A new AIDS-defining condition diagnosed within 30 days prior to screening or active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Day 0.
  • Cirrhosis of the liver
  • Screening or baseline ECG with clinically significant ECG findings.
  • Abnormal hematological and biochemical parameters, including:
  • Neutrophil count < 750 cells/mm(3)
  • Hemoglobin < 9 g/dL. If Hgb is < 11g/dL in women or < 12 g/dL in men. Other causes of anemia should be excluded as medically indicated.
  • Platelet count less than or equal to 50,000 cells/mm(3)
  • Estimated GFR (calculated by the CKD-EP(I) equation) < 50 mL/min/per 1.73 m(2) if not on ARV or < 60 mL/min if on ARVs
  • ALT or AST greater than or equal to 10 times ULN
  • Serum lipase greater than or equal to 1.5 times ULN (at screening or during the screening period)
  • Direct bilirubin greater than or equal to 1.50 times ULN
  • Albumin less than or equal to 3.0 g/dL
  • INR greater than or equal to 1.5 times ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
  • Donation or loss of more than 400 mL blood within 8 weeks prior to first dose administration.
  • Poorly controlled diabetes mellitus indicated by hemoglobin A1C > 10% at screening for known diabetics.
  • Known hypersensitivity to, GS-5885, GS-7977, or formulation excipients.
  • Pregnant/Breastfeeding women.
  • Co-enrollment in other clinical trials is restricted, and requires approval of the Investigator.
  • Study staff should be notified of co-enrollment status.
  • Need for use of the following medications from 21 days prior to the start of study drugs through the end of treatment:
  • Hematologic stimulating agents (e.g. erythropoiesis-stimulating agents (ESAs); granulocyte colony stimulating factor (GCSF); thrombopoietin (TPO) mimetics)
  • Chronic systemic immunosuppressants including, but not limited to, corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), azathioprine, or monoclonal antibodies (e.g., infliximab)
  • Investigational agents or devices for any indication
  • Medications for disease conditions excluded from the protocol (e.g., active cancer, transplantation) are not listed under this Concomitant Medication section and are disallowed in the study.
  • Concomitant use of certain medications or herbal/natural supplements per PI discretion expected to result in pharmacokinetic interactions resulting in increases or decreases in exposure of study drug(s) as listed in Table of this protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected With HIV

Background:

  • Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed to treat the hepatitis C virus (HCV) infection. They are still being researched and are not approved by the Food and Drug Administration. They are being developed as treatment for hepatitis C as a single pill taken once a day.
Read more

Objectives:

  • To determine whether a combination of the two study drugs can safely and effectively treat HCV infection in people with HIV infection and who do not have cirrhosis of the liver.

Eligibility:

  • Individuals who have HIV infection and have liver disease caused by infection with HCV.

Design:

  • Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required.
  • Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs.
  • Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.
Read the detailed description

Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the US an estimated 4.1 million people are infected with HCV which is the principal cause of death from liver disease and leading indication for liver transplantation. Significant advances have been made with the approval of directly acting antivirals (DAA) namely the protease inhibitors, telaprevir (TVR) and boceprevir (BOC) which have been shown to significantly improve rates of sustained virologic response (SVR). Response rates to these new combinations in HIV/HCV are also very promising, however treatment has been characterized with high rates of toxicities.

Recently several trials have confirmed the efficacy of potent DAA therapy without concomitant IFN in the treatment of HCV monoinfected individuals. Given the improved response rates achieved with a combination of DAAs with fast HCV suppression and improved side-effect profiles; and the need for better therapy for HIV/HCV co-infected subjects, we propose a study to determine the safety, tolerability and efficacy of 12 weeks of treatment with a fixed dose combination of GS-7977 and GS-5885 in HIV/HCV Genotype 1 (GT-1) subjects. We hypothesize that anti-HCV therapy that does not rely on the host immune system will provide an enhanced rate of SVR among HIV/HCV GT-1 coinfected subjects. The findings from this study will aid in our understanding of determinants of response to an IFN-free regimen in HIV/HCV coinfected individuals.

Conditions
Hepatitis C, HIV
Being tested
GS-7977/GS- 5885 FDC
Keywords
Direct Acting Antiviral, Treatment Naive, Interferon Sparing, Ribavirin Sparing
Medical subject headings
Hepatitis C

What participants receive

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

  • GS-7977/GS- 5885 FDCDrug

    The GS-7977/GS-5885 FDC product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor and will be given for 12 weeks.

Study groups in NCT01878799
Study groupRoleWhat they receive
HIVExperimentalSubjects with HIV and HCV
Receives: Drug: GS-7977/GS- 5885 FDC

What is being measured

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

  1. Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)

    The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.

    Measured: 12 weeks after completion of treatment

Timeline

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

  1. First posted17 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878799
Sponsor's protocol ID
130159
Other IDs
13-I-0159
Status last verified
Jul 2016
First submitted
14 Jun 2013
Last updated
15 Sep 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.

    PubMed 10451460

  • Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.

    PubMed 16702586

  • Kim WR. The burden of hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S30-4. doi: 10.1053/jhep.2002.36791.

    PubMed 12407574

  • Townsend K, Petersen T, Gordon LA, Kohli A, Nelson A, Seamon C, Gross C, Tang L, Osinusi A, Polis MA, Masur H, Kottilil S. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. AIDS. 2016 Jan;30(2):261-6. doi: 10.1097/QAD.0000000000000903.

    PubMed 26691547

  • Osinusi A, Townsend K, Kohli A, Nelson A, Seamon C, Meissner EG, Bon D, Silk R, Gross C, Price A, Sajadi M, Sidharthan S, Sims Z, Herrmann E, Hogan J, Teferi G, Talwani R, Proschan M, Jenkins V, Kleiner DE, Wood BJ, Subramanian GM, Pang PS, McHutchison JG, Polis MA, Fauci AS, Masur H, Kottilil S. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA. 2015 Mar 24-31;313(12):1232-9. doi: 10.1001/jama.2015.1373.

    PubMed 25706232

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-7977/GS- 5885 FDC in people with Hepatitis C and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 26 inclusion and 40 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: finished, as of the sponsor's last update on 15 Sep 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment) (time frame: 12 weeks after completion of 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 NCT01878799, which also lists 5 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 15 Sep 2016.

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