31 matching studies

Sponsor Condition of Interest
Investigating the Impact of Race on Gene-Expression Profiles in HIV Associated Neurocognitive Disorders
Rockefeller University Human Immunodeficiency Virus
HIV-Associated Neurocognitive Disorders (HANDs) are a pervasive and debilitating complication of HIV infection with an estimated prevalence of 30-45%. The identification of robust validated specific and sensitive biomarkers for HAND that do not require invasive CSF sampling has been elusive and is of... expand

HIV-Associated Neurocognitive Disorders (HANDs) are a pervasive and debilitating complication of HIV infection with an estimated prevalence of 30-45%. The identification of robust validated specific and sensitive biomarkers for HAND that do not require invasive CSF sampling has been elusive and is of paramount importance. However unrecognized racial differences in gene expression could significantly impact the predictive value of biomarkers of HAND if applied to populations in which they have not been developed or validated. We hypothesize that significant racial differences will be identified in the peripheral blood single-cell based gene-expression profiles of HAND. We further hypothesize that these differences may be largely attributed to delays in viral suppression and delayed/decreased access to care. To test these hypotheses we will use multivariate modeling to determine the relative influence of clinical and sociodemographic variables and social determinants of health on unbiased single-cell based gene transcriptional profiles in the peripheral blood of HIV-positive virally suppressed African American and Caucasian cohorts with and without HAND.

Type: Observational

open study

Developing Directly Reprogrammed Human Neurons to Investigate the Molecular Basis of Neurodegeneration...
Rockefeller University Human Immunodeficiency Virus
The prevalence of HIV-1 associated neurocognitive disorders (HANDs) is 30% . Advancing age is strongly associated with increased HAND prevalence and investigating the molecular basis of synaptodendritic injury and neurocognitive decline in this context... expand

The prevalence of HIV-1 associated neurocognitive disorders (HANDs) is 30% . Advancing age is strongly associated with increased HAND prevalence and investigating the molecular basis of synaptodendritic injury and neurocognitive decline in this context is paramount. Recently the ability to generate directly induced neurons (iNs) from patient-derived fibroblasts has been demonstrated. Unlike the immature neuronal populations generated from induced pluripotent stem cells (iPSCs) iNs reportedly retain aging-associated characteristics of the donor. In this proposal we aim to develop directly induced neurons (iNs) from HIVnegative individuals that retain age-associated transcriptional signatures. We will then determine if directly induced neurons (iNs) derived from HIV-positive individuals reveal age- and additional HIV disease-associated transcriptional signatures.

Type: Observational

open study

Assessing Adipose Tissue and Metabolic Profiles of Childhood Cancer Survivors after Radiation Therapy:...
Rockefeller University Childhood cancer
Due to advances in multimodality therapy 5-year survival rates for childhood cancer now exceed 80%. Survivors however face an increased lifelong risk of multiple treatment-related complications or "late effects" including insulin resistance metabolic syndrome and diabetes mellitus. Abdominal and total... expand

Due to advances in multimodality therapy 5-year survival rates for childhood cancer now exceed 80%. Survivors however face an increased lifelong risk of multiple treatment-related complications or "late effects" including insulin resistance metabolic syndrome and diabetes mellitus. Abdominal and total body irradiation have been implicated as key mediators of this process but the precise pathways by which they lead to metabolic derangement are poorly understood. Optimal methods for early detection also remain unknown. Recent evidence has suggested that abnormalities of adipose tissue or fat may play an important role in the pathogenesis of metabolic complications in childhood cancer survivors. The current project seeks to assess whether adipose tissue exposed to radiation demonstrates molecular and morphological changes when compared to adipose tissue that has never been exposed to radiation.

Type: Observational

open study

When the Kidney Reacts to Nutritional Changes
Rockefeller University Prehypertension
Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary... expand

Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary Approach to Stop Hypertension) diet is a proven effective intervention in lowering blood pressure in multiple populations. In this proof of concept study, volunteers with untreated stage 1 hypertension, defined as mild high blood pressure with numbers in the range of 130 - 139 over 80 - 89, will receive a DASH-based menu during 5 days of hospitalization, during a weekend at home where they will continue the menu, another 5 days as inpatients, followed by a weekend at home on the same menu, and the return to the inpatient unit for an additional day for final testing. Throughout the intervention period, participants will be followed clinically and undergo repeated laboratory testing. The aim of this project is to characterize changes in urine electrolytes and exosome protein abundance pattern during nutritional changes, shifting from a "westernized diet" to a DASH diet.

Type: Interventional

Start Date: Feb 2020

open study

A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505...
International AIDS Vaccine Initiative HIV Infections
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. expand

This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.

Type: Interventional

Start Date: Aug 2020

open study

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J,...
International AIDS Vaccine Initiative HIV-1-infection
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1... expand

This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels >10 µg/ml for at least 3 months in HIV-uninfected participants.

Type: Interventional

Start Date: Jan 2019

open study