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HIV Infections clinical trials

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NCT ID: NCT03600103 Not yet recruiting - HIV Infections Clinical Trials

Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV

Tech2Check
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Human immunodeficiency virus (HIV) infection has disproportionately persisted as a public health threat to adolescents and young adults (AYA) from minority communities in the United States. HIV has evolved into a chronic disease, which can be managed in the outpatient setting with antiretroviral therapy (ART) designed to achieve virologic suppression and life expectancy equivalent for uninfected individuals. Community health nurse (CHN) interventions have been shown to increase access to appropriate resources, enhance health care utilization, and promote risk-reducing behavior among AYA. Use of short messaging service (SMS) messaging can further enhance clinical care by improving attendance at medical visits, medication adherence, and communication with the health care team.Investigators have used these two modalities in randomized trials of youth with complex sexually transmitted infections (STIs) in low-income minority communities with high feasibility and acceptability amongst AYA and families, remarkable improvements in visit completion, medication adherence, and reduction in recurrent STIs. The overarching goal of this project is to build on the evidence from this trial and to re-purpose the intervention for Young people Living with HIV (YLHIV) in the same community who are having challenges with care and medication non-adherence.Investigators aim to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care control group using a randomized trial design. The central hypothesis is that the intervention will result in higher rates of adherence to ART and virologic suppression. Investigators have demonstrated investigators' interdisciplinary team's capacity to follow urban AYA in the community, utilizing the combination of CHNs and outreach workers to optimize care according to national standards. TECH2CHECK aims to enroll 120 YLHIV followed at clinics specializing in HIV care in the Baltimore-Washington Metropolitan area who are challenged with treatment adherence and randomizing participants to receive TECH2CHECK vs. standard of care. Results of this trial will inform best practices for engaging YLHIV by addressing the distal component of the continuum, critical to achieving the elusive 90-90-90 HIV goals.

NCT ID: NCT03599882 Recruiting - HIV Infections Clinical Trials

Liver Steatosis and Stiffness in HIV

Start date: August 1, 2018
Phase:
Study type: Observational [Patient Registry]

Background: With the advances in treatment and clinical care, individuals with human immunodeficiency virus (HIV) infection have experienced an increase in life expectancy. Liver disease is common among HIV-infected patients due to the shared routes of transmission of HIV and viral hepatitis. Nonalcoholic fatty liver disease (NAFLD) is the most common cause of elevated aminotransferases in HIV-monoinfected adults without HBV or HCV. Vibration-controlled transient elastography (VCTE) has been shown to have good sensitivity and specificity for assessment of liver fibrosis in HIV and viral hepatitis coinfected patients, as well as in HIV-negative NASH population. Controlled attenuation parameter (CAP), a novel physical parameter developed using the postulate that fat affects ultrasound propagation, measures the ultrasound attenuation at the center frequency of the FibroScan®. Study design: This is a prospective observational study. Objective: The aim of this study is to evaluate the liver steatosis and fibrosis in HIV-infected patients by noninvasive methods of VCTE and CAP. Methods: Patient number: 200 Inclusion criteria: 1. Age: 20-65 years 2. Males and females with HIV infection diagnosed by infection doctors 3. Willing and able to comply with the study requirements 4. Willing and able to provide written informed consent to participate in the study Exclusion criteria: 1. Pregnancy 2. Unable to complete the noninvasive procedure of VCTE and CAP 3. Unwilling to provide written informed consent to participate in the study

NCT ID: NCT03596918 Not yet recruiting - Clinical trials for AIDS-Related Kaposi Sarcoma

Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine

Start date: August 3, 2018
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies how well treatment with vincristine and bleomycin affect quality of life in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma.

NCT ID: NCT03595709 Not yet recruiting - HIV Infections Clinical Trials

Reduced-Dose EFV 400 mg Plus TDF and 3TC in Combination Tablet for Patients Receiving Atripla With Viral Suppression

Start date: August 15, 2018
Phase: Phase 3
Study type: Interventional

Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan

NCT ID: NCT03593655 Not yet recruiting - HIV Infections Clinical Trials

Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

Start date: November 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.

NCT ID: NCT03591003 Recruiting - HIV Infections Clinical Trials

"Persistence of Neutralizing Antibodies Against Yellow Fever (YF) in HIV-infected Patients"

Start date: June 2015
Phase:
Study type: Observational

Participating countries: Belgium Context: In June 2013, WHO notified that "a single dose of YF vaccine is sufficient to confer sustained life-long protective immunity against YF disease and that a booster dose is not necessary". . For HIV infected persons the recommendation was less stringent and the position paper concluded that hiv infected persons may "hypothetically, benefit from a second dose or booster dose ".1 Recently, WHO changed the recommendations about a booster dose of YF vaccine, based on the fact that serum neutralizing antibodies against YF are still at detectable levels after 20-35 years and probably lifelong in immunocompetent patients. Unfortunately, data on persistence of Neutralizing antibodies Titers (NT) in immunocompromised patients are missing and only few studies reported data about HIV-infected patients. Additional data are needed. Primary objective: To assess presence / persistence of Neutralizing Titers (NT) of antibodies after YF immunization in HIV-infected patients. Secondary objectives: 1. To identify risk factors for early and late waning of NT after YF immunization 2. To modelize kinetics of NT after YF immunization in different subpopulations of HIV patients, including population of young HIV patients infected vertically 3. To identify risk factors for absence of seroconversion in the year after YF immunization 4. To compare persistence of NT in HIV patients infected vertically or not vertically 5. To quantify seroconversion rate after YF vaccination Methodology / study design This study is a single arm, non randomized, cross-sectional, multicenter study in AIDS Reference Centers from Belgium. The maximum duration of the study for each patient will be 1 visit, consisting of: - the screening and inclusion visit (single visit V1) to check the patient eligibility, sign informed consent, perform the biologic tests necessary for the study and answer the questionnaire - whenever possible, an additional serum / plasma sample coming from serabank / plasmabank will be identified for each patient. This sample must have been taken during the year following YF immunization. - data about patient's HIV history has to be extracted from the HIV database or from patients' file Estimated enrolment 750 patients + 30 patients infected vertically with HIV Primary outcome Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization Secondary outcomes 1. Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization 2. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) for absence of seroconversion in the year following YF immunization 3. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of early waning (before 10 years) of YF NT 4. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of late waning (after 10 years) of YF NT Eligibility Inclusion criteria 1. Infection with HIV-1 (vertical transmission or not) 2. Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of vaccine administration 3. Informed consent signed prior to any study procedure Exclusion criteria Inability to give informed consent Substudies - Whenever possible, an additional sera or plasma sample from the year following YF vaccine will be selected and analyzed to assess early seroconversion rate - Whenever possible, an additional sera or plasma sample from the year before YF vaccine will be selected and analyzed to assess seroconversion rate - In CHU Saint-Pierre, an additional cohort of patients infected vertically with HIV will be selected and will participate to the study

NCT ID: NCT03586128 Recruiting - HIV Infections Clinical Trials

Partners PrEP Program

PPP
Start date: June 8, 2018
Phase:
Study type: Observational

Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.

NCT ID: NCT03583138 Completed - Clinical trials for Human Immunodeficiency Virus

HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)

Start date: June 23, 2014
Phase: Phase 4
Study type: Interventional

STRIDE2 is a longitudinal, non-randomized study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University.

NCT ID: NCT03581305 Recruiting - HIV Infections Clinical Trials

PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects

Start date: August 17, 2018
Phase:
Study type: Observational

Background: Human immunodeficiency virus (HIV) infection is a serious disease with no cure. Some people with HIV have depression and other mood problems. They can have problems with thinking and memory. Researchers think 2 chemicals in the brain may cause those problems. The chemicals are serotonin and dopamine. The researchers want to take images to learn more about those chemicals in HIV patients. Objective: To learn how HIV affects serotonin and dopamine in the brain. Eligibility: Adults ages 18-66 with HIV who have been on antiretroviral treatment for at least 1 year Healthy adults ages 18-66 All participants must be already enrolled in protocol 13-N-0149. Design: - Participants will be screened with a urine drug test. The results could be shared with insurance companies. - Participants who could be pregnant will have a pregnancy test. - Participants may have a physical exam and blood tests. - Participants will have 1 or 2 positron emission tomography (PET) scans. A needle will guide a thin plastic tube (catheter) into an arm vein. A radioactive drug will be injected into the plastic tube. This is a tracer that helps researchers understand the PET images. - Participants who have the dopamine scan will have to fast for 4-6 hours before the scan. They will take a pill to help direct the tracer to the brain one hour before the scan. - Each scan will last about 1.5 hours. - Participants will be asked to drink a lot of fluids and empty their bladder frequently for the rest of the day after each scan.

NCT ID: NCT03579576 Recruiting - HIV Infections Clinical Trials

Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar

Start date: December 20, 2017
Phase:
Study type: Observational

The project will evaluate cost and treatment outcomes of a simplified hepatitis C virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations including people who inject drugs (PWID) in Myanmar.