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HIV Infections clinical trials

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NCT ID: NCT03500302 Not yet recruiting - Clinical trials for Coronary Artery Disease

Effect of Evolocumab on Coronary Endothelial Function

Start date: April 18, 2018
Phase: Phase 2
Study type: Interventional

The investigators propose a pilot study using (1) MRI to assess coronary artery endothelial function, (2) brachial ultrasound to assess systemic endothelial function, (3) serum markers of inflammation and of endothelial cell function and (4) echocardiographic measures of left ventricular diastolic and systolic properties, before and following initiation of PCSK9 antibody in HIV positive subjects.

NCT ID: NCT03499795 Not yet recruiting - Anal Neoplasm Clinical Trials

VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2

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

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

NCT ID: NCT03497676 Not yet recruiting - HIV Infections Clinical Trials

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

Start date: July 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the dosage for oral and IM Cabotegravir LA and IM Rilpiverine LA and evaluate the safety, acceptability, tolerability, and pharmacokinetics of oral and long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed HIV-infected children and adolescents.

NCT ID: NCT03495570 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic/Acute Viral Infections

Start date: April 15, 2018
Study type: Observational

The XN-20, is a full blood count (FBC) analyser with an extended differential counting and flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses a two stage process to classify the white blood count (WBC) sub-populations and detect the presence of abnormal reactive and malignant cells. In regards to lymphocytes in the peripheral blood, the machine has the capacity to distinguish activated from non-activated T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from a standard full blood count) with results available in 1.5 minutes. It is a fully automated process and can be considered as an alternative rapid flow cytometry method. Objective of the SASA study: to investigate the signal pattern of white blood cells assessed using the XN-20 full blood count platform in patients with untreated viral infections i.e. HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's demographic and clinical disease characteristics with the aim of detecting characteristic cell populations that can be used in the development of system flags for future studies.

NCT ID: NCT03482739 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine in HIV and Transplant Patients

Start date: March 2018
Phase: Phase 3
Study type: Interventional

This is a single-center, open-label study on safety, tolerability and immunogenicity of Gardasil®9 in 18 to 45 year-old HIV patients, in 18 to 55 year-old solid-organ transplant (SOT) patients. This study will enrol 140 HIV patients with CD4+ count of >200cells/mm² and 170 SOT patients, all of whom have not yet received a prophylactic HPV vaccine. The 170 SOT patients will be equally divided over 3 different SOT patient groups, namely heart, lung and kidney transplant patients. Therefore the target is to include approximately 57 heart transplant patients, 57 lung transplant patients and 57 kidney transplant patients. Enrolment in a SOT subgroup will be stopped when 57 patients have been included unless recruitment cannot be achieved within one of the other SOT-patient population. All enrolled subjects will receive a 3-dose regimen (Day 1, Month 2, and Month 6) of GARDASIL®9. Serum samples will be collected on Day 1 and Month 7 for anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody determination. The time point for comparison of immune responses will be Month 7, or approximately 4 weeks after the administration of the third dose. The safety/tolerability profile of the vaccine will be evaluated in all subjects in the study. Safety information will be collected on Day 1 through 1 month following the third vaccination or for a total of approximately 7 months for each subject. The immunogenicity and the safety data will be analyzed per group of patients. More specifically a separate analysis of HIV and SOT patients is planned, since it is expected that the immunosuppressive therapy of SOT patients might have a more profound effect on immunogenicity following vaccination. This study will provide a comparison of immunogenicity of Gardasil ®9 in immunocompromised patients, with historical controls. The number of subjects to be enrolled in the study was determined based on the primary immunogenicity objective.

NCT ID: NCT03480802 Not yet recruiting - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY)

Start date: July 9, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.

NCT ID: NCT03465852 Not yet recruiting - HIV Infections Clinical Trials

HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

Wake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use.

NCT ID: NCT03441984 Not yet recruiting - HIV Infections Clinical Trials

To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers

Start date: February 21, 2018
Phase: Phase 1
Study type: Interventional

This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.

NCT ID: NCT03435783 Not yet recruiting - HIV Infections Clinical Trials

Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

Start date: February 16, 2018
Phase: N/A
Study type: Interventional

The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.

NCT ID: NCT03413683 Not yet recruiting - HIV Infections Clinical Trials

Frailty in Older HIV-infected Individuals

Start date: April 2018
Study type: Observational

Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected individuals in Hong Kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in HIV-infected individuals in Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and without frailty. The following assessment will be done: 1. Physical examination including measuring height, weight, hip and waist circumference. 2. Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests 3. Geriatric syndromes, screening for depression, disability and quality of life. 4. Blood tests during fasting state to measure metabolic parameters. This is a prospective longitudinal observational study that lasts for 10 years.