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HIV Infections clinical trials

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NCT ID: NCT03502005 Recruiting - Clinical trials for Human Immunodeficiency Virus

Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).

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

Effect of Evolocumab on Coronary Endothelial Function

EVOLVE
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

MOCHA
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

SASA
Start date: April 15, 2018
Phase:
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: NCT03489421 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Mitochondria in HIV and Aging (MITO+)

(MITO+)
Start date: April 15, 2018
Phase:
Study type: Observational

Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Furthermore, the investigators hypothesize that the older antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide (TAF).

NCT ID: NCT03489109 Recruiting - Metabolic Syndrome Clinical Trials

2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome

Start date: April 25, 2018
Phase: Phase 1
Study type: Interventional

Background: Weight gain can lead to obesity and diabetes even in people living with human immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie restriction can help overweight people with HIV as an alternative to traditional diets. Objective: To see if intermittent calorie restriction leads to weight loss and improved blood sugar in obese people with HIV. Eligibility: Adults ages 18-65 with HIV who are obese and do not have diabetes Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Before starting treatment, participants will: - Have a nutritional consultation - Get a pedometer to record daily steps - Test a restricted diet for 1 day - Have a body x-ray At the baseline visit, participants will have: - Blood drawn after they drink a sugar drink - Questions about their health and eating - A nutritional consultation - Resting energy expenditure measured. Participants will fast overnight. Then they will lie down while a plastic bubble goes over the head and a plastic sheet covers the upper body. Oxygen flows into the bubble. - Liver stiffness test. A wand on the stomach releases sound waves like an ultrasound. For 12 weeks, some participants will be on a standard diet. Others will restrict how much food they eat 2 days a week. On those days they will eat about 25% of their recommended calories. Participants will keep a diary of their diet and steps. Participants will have 4 visits during the 12-week diet and 1 visit 12 weeks after the diet ends. They will repeat previous tests.

NCT ID: NCT03485963 Recruiting - HIV Infections Clinical Trials

HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals

Start date: May 2018
Phase: Phase 1
Study type: Interventional

This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).

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™.