33 Clinical Trials for Various Conditions
End-stage liver disease, predominantly due to hepatitis C virus (HCV) infection, is one of the leading causes of death in person living with HIV infection. While HCV is curable and recent advances in treatment have increased the rates of cure, few patients with HIV and HCV are being treated to cure HCV. Based on formative research, the investigators developed the "Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C)". PREP-C is a clinical interview that healthcare providers of diverse disciplines can be trained to administer. It provides an assessment of a client's psychosocial readiness to begin HCV treatment and identifies domains of functioning which require intervention to improve treatment readiness. PREP-C (www.prepC.org) is also a telemedicine resource for health care providers. Under this protocol, the existing PREP-C clinical interview (or assessment) is incorporated with a behavioral intervention. This study tests the integrated assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected patients. The assessment-behavioral intervention under this protocol is conducted in two phases, an Intervention Development phase and a Pilot Randomized Clinical Trial (RCT) phase. Findings from this vanguard study will inform the design parameters of a larger, more rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based assessment and intervention package is designed to be scalable and can be disseminated through the live PrepC.org web site. The proposed study is innovative in that it seeks to develop the first web-based intervention for health care providers to use to increase HCV treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health impact by providing needed structured resources for health care providers to increase rates of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to end-stage liver disease.
Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged survival in infected individuals. As a result, other diseases are now becoming clinically significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.
The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS, HIV/HCV co-infection, mild HCV and healthy subjects.
Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)
This randomized controlled trial was implemented to evaluate the effect of integrating rapid Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults in a New York City Emergency Department participated in the study. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public Health Advocates approached eligible patients in the Emergency Department, performed HIV and HCV raid testing, and delivered test results to participants with post-test counseling. The primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether the addition of an HCV test adversely impacted participants' consent to test for HIV. Questionnaires were also distributed to participants to assess HCV knowledge.
The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. Specific Aims: To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal liver biopsy as part of their routine clinical care 2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis 3. To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography
The purpose of this research study is to explore what role immune cells within the gut (the sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or HCV/ HIV co-infection.
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
Background: - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness, including liver cancer, and even death. This study will follow people who have hepatitis B or hepatitis C. The purpose is to understand more about how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS. Objectives: * To do a long-term study of hepatitis B and hepatitis C infection. * To study the effects of hepatitis B and hepatitis C infection in people do and do not have HIV. Eligibility: - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care. Design: * Participants will be screened with a physical exam and medical history. Those who do not have a regular doctor to provide medical care during the study will not be able to take part. * Participants will have yearly visits with study researchers for up to 10 years. These tests will be done at each visit. * Medical history and physical exam. * Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and quality of life. * Blood and urine tests, including HIV testing. * Tissue sample collections for those who have had a liver or other tissue biopsy. * Participants may leave the study at any time. They will receive the standard of care from their regular doctor throughout the study.
The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.
Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.
This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.
This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive for antibodies to this virus. Most HCV-infected people do not become ill and are not aware that they have hepatitis or have had it in the past. Some infected people recover completely, whereas others remain chronically infected. The study will try to define infectivity of anti-HCV positive individuals, routes of transmission of the virus, and the number of HCV-infected persons who have evidence of liver disease. Blood donors at the NIH Clinical Center or the Central Maryland Chapter of the American Red Cross who test positive for HCV may be eligible for this study. Participants will have a physical examination and history, including questions about socioeconomic status and current sexual practices. They will have 100 milliliters (ml) (6 tablespoons) of blood drawn at the first visit and 50 ml (3 tablespoons) drawn 3, 6, 9 and 12 months after the initial visit. Some participants may undergo plasmapheresis, a procedure for collecting additional plasma (the liquid portion of the blood). For this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The plasma is then removed, and the red and white cells and platelets are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. In some individuals, other body fluids (saliva, urine or semen) may also be collected. Participants may be asked to bring their household contacts and sexual partners to NIH for interview and blood testing for evidence of HCV infection and liver disease. Although this is not required for participation in the study, it would provide additional valuable information. Participants found to have chronic viral infection will be seen more often and will provide additional blood samples for routine medical care. Further medical evaluation may include X-rays or liver scans and referral to a specialist for additional tests or therapy. Ten people in this study will be recruited to participate in a secondary investigation to analyze changes in the level of HCV and the immune response to it, and to relate these changes to the degree of liver damage. In addition to blood collected for the primary study, participants in this investigation will have an additional 50 ml (3 tablespoons) of blood drawn from an arm vein every week for 10 weeks to measure levels of virus, ALT (a liver enzyme), and immune response.
Background: * Chronic hepatitis C (CHC) is a major health problem that particularly affects individuals with human immunodeficiency virus (HIV) infection, and can lead to cirrhosis and liver failure. Standard treatment for people with HIV and CHC is a 48-week course of pegylated-interferon alfa 2a (peg-IFN) and ribavirin (RBV), but better treatments are needed for those who either do not respond to the drugs or who relapse after treatment. * Nitazoxanide has been approved by the Food and Drug Administration primarily to treat diarrhea caused by parasites, and it has been studied in the treatment of CHC infection. However, it has not been tested in persons infected with HIV and CHC co-infection. Researchers are interested in determining whether nitazoxanide is a safe and tolerable treatment for CHC in individuals with HIV. Objectives: - To assess the safety and tolerability of using nitazoxanide to treat chronic hepatitis C infection in individuals with HIV who have not responded to standard treatment for hepatitis C. Eligibility: - Individuals at least 18 years of age who have been diagnosed with both HIV and chronic hepatitis C, and who have either not responded to or relapsed after previous hepatitis C treatment. Design: * Participants will be screened with a physical examination and medical history; blood and urine tests; imaging studies; possible heart, lung, and psychological tests; and a liver biopsy if one has not been done in the past 3 years. * Participants will receive nitazoxanide, the medication being studied, to take by mouth for 4 weeks, and will provide blood samples during this time. * After 4 weeks, participants will receive the first dose of peg-IFN and RBV. Participants will have weekly injections of peg-IFN and continue to take nitazoxanide and RBV by mouth for 48 weeks. Individuals who are slow to respond to this combined CHC treatment (nitazoxanide, peg-IFN, and RBV) by week 12 will continue to have the combined treatment for an extended period, a total of 72 weeks. * Participants will have study visits to provide blood samples and have other tests two times in the first month of combined treatment, and then at months 2, 3, 4, 7, 10, 13, 19; and month 25 only in participants slow to respond to combined treatment. * Some participants who are on specific HIV treatment regimens may enroll in a substudy that will require three separate 12-hour visits for repeated blood samples and other tests during the initial 4-week nitazoxanide treatment.
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.
Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this usually occurs more rapidly among people infected with both HCV and human immunodeficiency virus (HIV). People infected with both HCV and HIV have poor response to the current HCV treatments. This phase II pilot study evaluated whether adding a new HCV medication improves response to the current standard HCV treatment with pegylated interferon and ribavirin in people with both HCV and HIV.
Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA \< 6 x106 IU/mL Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
Background: - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: - To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: - Adults who need treatment for chronic Hepatitis C infection. Design: * Participants will be screened with blood tests. Their current medicines will be reviewed. * Participants will give researchers access to their medical records. Researchers will follow participants through these records. * Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. * Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. * Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. * Participants will have yearly follow-up visits with their care provider for up to 10 years.
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.
This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits in people who are infected with both HIV and the hepatitis C virus.
The purpose of this study is to measure the effects of anti-HIV drugs on hepatitis C virus (HCV) viral load in people infected with both HCV and HIV.
* Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV. * Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection. Objectives: - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. This is an observational study. The observed treatment is received and managed through their primary care.
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.
Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of this study is to determine whether treatment with pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom previous treatment with peginterferon and ribavirin was unsuccessful.
Background: Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections. Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression. Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens is becoming increasingly common, particularly amongst intravenous drug users, who account for approximately 25% of the HIV-1 epidemic in the United States. Objectives: The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical progression of HIV1 to AIDS in hemophiliacs. Eligibility: The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study (HGDS). Design: This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study (HGDS) as part of a grant "Pathogenesis of HIV and HCV in Hemophilia: HGDS-3" with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005. This multicenter, United States study represents a well-characterized, prospectively followed cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected. Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or clinical data will be collected on this population. The LGD plays two roles in this project: (1) an administrative role overseeing the withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication..