126 Clinical Trials for Various Conditions
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.
This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender male couples who are in a relationship (defined as greater than 3 months or more).
This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails or otherwise involved in the criminal justice system. This study will compare people in a health linkage intervention with people who will get overdose (OD) education. Everyone will take part in the baseline and follow-up surveys and receive OD education. Participants will be assigned to one of the two groups by chance based on when they are enrolled to the study and if their county is randomly assigned to an intervention or a comparison condition. By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C virus (HCV), and overdose education to people leaving rural jails or otherwise involved in the criminal justice system will reduce substance use and related harms.
AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.
The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study was to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who were taking antiretroviral (ARV) therapy.
The purpose of this study is to find out how many children who are infected with HIV are also infected with hepatitis C virus (HCV). HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV appear to have more rapid HIV disease progression. There is little data on how widespread HCV is among children who are HIV-infected. Information from this study will help determine the need for future HCV studies. This study also will obtain blood samples for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).
This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that helps to reduce the body's resistance to insulin. It is approved by the Food and Drug Administration to treat diabetes. Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis. * Participants are randomly assigned to take either pioglitazone therapy or placebo for 48 weeks. This is followed by a second 48-week treatment period in which all participants take pioglitazone. * There are approximately 12 visits during the 96 weeks of the study. Participants will receive a physical assessment, blood and urine tests at each visit. In addition, periodic assessments of dietary habits, body composition, oral glucose tolerance testing, and health related quality of life questionnaires will be completed. * A repeat MRI of the liver is performed at 48 weeks and at the end of the study to evaluate any potential changes in liver fat and inflammation. In addition, there is a follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.
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.
Objectives: Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy). Secondary * To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV). * To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24 Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg and \< 105 kg * 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either: * Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment. * Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment. Study Population: 300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy. Dosage and Administration: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg and \< 105 kg * 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b and Ribavirin dosages will be obtained. Safety Evaluations: * Assessment of laboratory evaluations * vital signs * incidence and severity of adverse experiences * dose adjustments * premature withdrawal for safety reasons * progression of disease as measured by HCV viral load * AIDS defining events
Objectives: Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic response following previous interferon therapy. Secondary * To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values. * To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4, 12, and 24 as compared to baseline. * To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values. * To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy. * To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease. Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks. * Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks. * Group B: No CHC therapy for 72 weeks All patients entering the study are required to have a baseline liver biopsy (within 18 months of study entry). Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial. Study Population: 100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy. Dosage and Administration: Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: * 800 mg (400 mg bid) if body weight \< 65 kg * 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg * 1200 mg (600 mg bid) if body weight \> 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly. Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2a and Ribavirin dosages will be obtained. Safety Evaluations: * Assessment of laboratory evaluations * vital signs * incidence and severity of adverse experiences * dose adjustments * premature withdrawal for safety reasons * progression of disease as measured by HCV viral load * AIDS defining events
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).
This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.
The purpose of this study is to find if the Single Photon Emission Computed Tomography (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV). A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT scan, which takes a picture of the liver, has been found to be effective in determining liver damage but studies need to be done in patients with hepatitis. This study will compare the effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is found to be as good as or better than liver biopsies.
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 purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV. Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.
Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+ cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals, patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis, which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death. Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury may offer an immunologic platform to determine factors associated with progressive liver fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV and HCV coinfection patients with well-controlled HIV infection who have an undetectable viral load exhibit abnormal levels of inflammation and immune activation, potentially contributing to advanced liver fibrosis. Comparative groups include coinfected patients successfully treated for hepatitis C, or who have absence of hepatitis C viremia through spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by non-invasive methods. The primary objectives of this study are: 1. To determine if there are differences in markers of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection. 2. To assess the stage of liver fibrosis using non-invasive methods in subsets of patients with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver fibrosis with levels of inflammation and immune activation.
There is some information available that indicates that Milk Thistle is an effective treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine that looks just like Milk Thistle but does not contain any Milk Thistle) to see if people with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C. The study will last one year.
The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).
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.
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.
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy. IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.