Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV

Completed · Phase 2

Conditions studied: HIV-HCV

In brief

Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV alone in HCV monoinfected patients, treatment is still associated with a high incidence of adverse events (AEs), discontinuations and poor cure rates in several populations. Within the HIV/HCV co-infected population treatment for HCV remains complicated given drug interactions between anti-retrovirals and HCV protease inhibitors, in addition to the extensive side-effects due to PEG +RBV alone. Recent studies have demonstrated that the use of a combination of anti-virals which target HCV without interferon (IFN) can cure HCV, without additional toxicities. These novel therapies that do not rely on an IFN backbone may additionally enhance cure rates in HIV/HCV co-infected, a population which has historically been difficult to cure. The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.

Key facts

Study ID

NCT02124044

Run by

National Institutes of Health Clinical Center (CC)

People needed

30

Starts

2014-02-01

Expected to finish

2016-11-01

Last updated by the study team

2017-05-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 the subject treatment, assessment of compliance with the protocol; subjects currently under evaluation for a clinically-significant illness (other than HCV) are also excluded
• Gastrointestinal disorder with 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)
• Hepatic impairment (e.g., Child-Pugh class B [moderate] or Child-Pugh class C [severe])
• 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)
• Positive nucleotide sequence analyses of the NS5A gene for Y93H or L31M/V polymorphisms for the 2DAA arm only.
• Positive test results at screening for hepatitis B virus (HBV) surface antigen (HBsAg) or HBV RNA (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 date screening consent is signed or active serious infection (other than HIV and HCV), requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Day 0
• Abnormal hematological and biochemical parameters at screening, unless the test has been repeated and at least one subsequent result is within the acceptable range prior to study drug administration, including:
• Neutrophil count <750 cells/mm3
• Hemoglobin level <9 g/dL
• Platelet count less than or equal to 50,000 cells/mm3
• Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: <50 mL/min/1.73 m\^2
• ALT or AST level greater than or equal to10 times upper limit of normal (ULN)
• Serum lipase level greater than or equal to 1.5 times ULN at screening or during the screening period in a patient with symptoms of pancreatitis
• Total bilirubin level greater than or equal to 2.0 times ULN, except in subjects with Gilbert s syndrome
• Albumin level less than or equal to 3.0 g/dL

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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