162 Clinical Trials for Various Conditions
Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.
Background: Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected. Objectives: To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy. Eligibility: Data were collected from adults 18 and older in studies that were done in 2012 and 2016. Design: Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment. Researchers will take data from those records. This will include data on: * Age, sex, race, and ethnicity * Treatment and disease status * Lab results Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.
Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.
Background: - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people. Objective: - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs to treat or prevent virus infections. Eligibility: - Healthy adults age 18 or older. Design: * Participants will be asked questions about their health history, including sexual activity and drug use. They will give blood samples. They may have a physical exam. They may give a urine sample. * Participants may have the inside of their nose either swabbed or washed with some fluid. The fluid will be collected. They may give a stool sample. * Participants may have an electrocardiogram. Soft, sticky patches will be attached to participants chest, arms, and legs. They will lie still on a table while the patches detect the heart s electrical signals. A machine will record these signals. * Participants may have lung function tests. These tests measure the volume of air moving in and out of the lungs. Participants will forcibly blow air into a machine. * Participants will be told if any tests show a medical problem. * If a participant is eligible and decides to join an investigational clinical trial, researchers will explain the study and the risks involved. Participants will sign a separate consent for that clinical trial.
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Data from this study will be used to decide how VH4524184 can be best included in a full-treatment regimen for HIV-1 in the future.
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks.
People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV). Successful HCV treatment leading to sustained viral response (SVR) is associated with increased survival, but to date successful treatment of PWIDs has been limited. Treatment of PWIDs is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. At Albert Einstein College of Medicine, the investigators have developed a multidisciplinary model of HCV care that integrates on-site primary care, substance abuse treatment, and HCV-related care within opiate agonist treatment clinics. To optimize HCV treatment outcomes, the investigators have introduced directly observed therapy (DOT). In the DOT model, one daily dose of oral HCV medication is administered with methadone. However, DOT is not feasible for PWIDs who are not enrolled in methadone maintenance treatment programs, and is less effective for methadone-maintained PWIDs who do not attend the methadone clinics every day. In addition, DOT has been used for decades both to measure and maximize adherence for treatment of tuberculosis infection, but the cost and logistical complexity of administering DOT for large HCV clinical programs would be prohibitive.
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive, so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe DAAs because they are concerned that PWID won't take their medication or that these patients might become reinfected. Several good models for treating PWID exist. One of them is to provide directly observed treatment (DOT). Another model provides treatment to PWID with the support of patient navigators (PN), public health workers who offer support and education to patients. Though both the DOT and PN models have been successful, we still don't know which model works best. In this study, the investigators will study both DOT and PN models for treating HCV in PWID. The investigators' goal is to find out which model produces the best results and is preferred by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites around the country. Patients will be randomized into either the PN or the DOT groups. Patients who end up in the PN group will get a biweekly blister pack of medication to take home. Their PN will provide education and support. The investigators will find out whether patients adhered to medication using an electronic adherence monitoring system. Patients who are randomly assigned to the DOT group will take their medication in front of a staff member.
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care. PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs. PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen. PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.
The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.
RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic advanced solid tumors.
This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure.
Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.