View clinical trials related to HIV Infections.
Filter by:This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).
This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).
This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide the advanced knowledge, skills, and experience for the candidate's career transition to an independent nurse scientist. Her long term goal is to become a leading nurse scientist in designing, implementing, and evaluating technology supported behavioral interventions targeted for improved disease self-management (i.e. medication adherence, retention in care) among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre and post-doctoral interdisciplinary research traineeships, the candidate has begun to develop the knowledge-base and skills necessary for this goal. This award details a 3-year scope of mentored career development through which she will gain the foundation for future research endeavors. Specifically, the goals of this proposal are to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of expert researchers; 2) acquire expertise in health informatics for implementation of technology supported behavioral interventions, health disparities, and advanced qualitative and mixed methods design and analysis through firsthand experience, didactic interactions with mentors, and graduate level coursework; 3) build a network of colleagues and collaborators within New York University and elsewhere through this research and participation at national and international meetings; and 4) prepare and submit a federal research grant (R-21) based upon the skills and findings from this award period. The specific research project through which she will accomplish these goals is a proof of concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and addresses the challenge of adherence to antiretroviral treatment among HIV-infected adolescents and young adults. A mixed method design is proposed and the specific aims are to: 1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive behavioral intervention delivered via remote videoconferencing using smartphones; 2) Obtain initial estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported ART adherence, beliefs and knowledge about antiretroviral treatment, adherence self-efficacy, and healthcare utilization (retention in HIV care). In summary, the ACCESS adherence intervention is consistent with the National Institute of Nursing Research (NINR) call for the development of novel interventions to deliver personalized care and real-time health information for patients.
Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune activation and trafficking of activated and HIV-infected cells to the central nervous system (CNS), and limiting establishment and persistence of the CNS reservoir of HIV. At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of telmisartan augmentation), the investigator expect subjects in the telmisartan group will have reduced levels of blood and CSF immune activation markers, reduced brain inflammation, lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance. Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48 weeks develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks. Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this study. Number of subjects: 21 Duration of follow-up: 72 weeks Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and neuropsychological testing and exam will be collected at baseline, week 48 and week 72. Inguinal lymph node biopsy is an optional procedure that will be offered at baseline and week 48.
The overall objective is to determine the influence of timing of ART initiation and alcohol consumption on HIV disease course. ART initiation immediately after HIV infection largely results in smaller HIV reservoir and lower HIV-associated systemic inflammation, which has been linked to non-AIDS morbidity and mortality. Immediate ART also reduces HIV-associated bacterial translocation and may prevent intestinal microbiome dysbiosis, that has been linked to increased systemic inflammation. Immediate intervention is not, however, generally feasible and more information is required about the consequences of starting ART at later time-points, but still early after acquisition. The study will be conducted in Lima, Peru, in a cohort of 180 MSM and transgender women (TW) with acute (Ab-, HIV RNA+) or recent (≤ 3 months) HIV infection. Alcohol use disorder (AUDIT score ≥8) is present in ~50% of HIV + participants in our cohort, four times higher than that seen among males in the general Peruvian population. Although the role of alcohol use in HIV pathogenesis and disease course remains unclear, some studies show a correlation with accelerated disease progression. The effects of alcohol resemble early post-infection changes in bacterial translocation and pro-inflammatory cytokines induced by HIV and their impact on HIV disease course before and after ART initiation remain unexplored. Specific Aim 1: To determine the relative long-term benefits of immediate vs. early vs. delayed ART initiation at 24 weeks after diagnosis. The investigators will study outcomes after 2 and 4 years in MSM and TW diagnosed with acute or recent HIV infection. Specific Aim 2: To determine the impact of alcohol use on the relative long-term benefits of immediate vs. early vs. delayed initiation of ART.
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.
The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg versus co-administration of the separate tablet formulations of DTG 50 mg plus RPV 25 mg, in the fed state. This pivotal bioequivalence study, is to serve as a pharmacokinetic (PK) bridge to the ongoing Phase 3 trials with the separate agents. This study will be conducted under fed conditions to appropriately mimic the conditions in the Phase 3 trials. This is a single-center, randomized, open-label, 2-period, single-dose, crossover study. A minimum of 86 healthy adult subjects will be randomized such that a minimum of approximately 82 evaluable subjects complete the study. The total duration of participation of a subject in this study will be approximately 8 weeks which includes a screening visit within 30 days prior to the first dose of study drug, two treatment periods each with a single dose of study drug and a follow-up visit within 12-17 days after the last dose of study drug. There will be a washout of at least 21 days between each dose of study drug. A blinded (for treatment) review of DTG and RPV plasma concentration data for approximately the first 40 subjects will be conducted. If the within-subject coefficients of variation (CVw%) for either DTG or RPV maximal drug concentration (Cmax) values are >=31%; a sample size re-estimation will be employed and additional subjects (beyond the 86 planned) will be randomized for treatment in the study. Following the re-estimation, it is possible that up to approximately 154 healthy adult subjects (68 new subjects in addition to the planned 86 subjects above) will be randomized such that a maximum of approximately 146 evaluable subjects could complete the study.
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.
The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue. Primary Objective: - To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Secondary Objectives: - To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. - To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue. - To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Observational Objective: - To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.