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

Completed · Phase 2

Conditions studied: Hepatitis C, HIV

In brief

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. 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.

Key facts

Study ID

NCT01878799

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

2013-06-01

Expected to finish

2014-09-01

Last updated by the study team

2016-09-15

Who can join

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

You may not qualify if…

• 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).
• 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)

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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