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HIV Infections clinical trials

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NCT ID: NCT03577470 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate

DIAMANTE
Start date: June 13, 2018
Phase:
Study type: Observational

The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.

NCT ID: NCT03577301 Completed - HIV Infections Clinical Trials

Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse

YMHP
Start date: October 4, 2018
Phase: N/A
Study type: Interventional

YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.

NCT ID: NCT03575962 Completed - HIV Infections Clinical Trials

A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254

Start date: June 18, 2018
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTIH), 2-period study, to assess the relative bioavailability of a mesylate salt capsule of GSK3640254, compared to a bis- hydrochloride salt capsule of GSK3640254, in healthy subjects, administered following a moderate calorie and fat meal. The subjects will be randomized to 2 sequences, Regimen AB or Regimen BA. For Regimen AB: The Regimen A, which will include oral administration of GSK3640254 bis-hydrochloride Capsule 200 milligram (mg) (reference), which will be administered, in Period 1 and Regimen B will include GSK3640254 Mesylate salt capsule (test), 200 mg, which will be administered in Period 2. For the regimen BA, the regimen B, will be administered, in Period 1 and regimen A, in Period 2. Each of the regimens will be given orally as 2 capsules in the morning, as per randomization sequence. There will be a minimum washout of 7 days between each dose of study treatment. A total, of 14 subjects, are planned to be enrolled in the study. The maximum duration of the study from screening to follow-up is approximately 7 weeks.

NCT ID: NCT03575143 Completed - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV

PLWH/OSA
Start date: August 2, 2018
Phase:
Study type: Observational

The investigators seek to understand how the different underlying causes of OSA affect the way people living with HIV (PLWH) experience OSA. The investigators also want to understand how symptoms of obstructive sleep apnea improve with treatment, and if this too, is affected by the underlying cause of OSA in that individual

NCT ID: NCT03569813 Completed - HIV/AIDS Clinical Trials

Pre-exposure Prophylaxis (PrEP) at Home

PrEP@Home
Start date: April 26, 2019
Phase: N/A
Study type: Interventional

This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.

NCT ID: NCT03569592 Completed - Clinical trials for Drug Overdose Accidental

Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS

Start date: January 22, 2018
Phase: N/A
Study type: Interventional

The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations. The research has the following aims: - Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated; - Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and - Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.

NCT ID: NCT03568812 Completed - HIV Infections Clinical Trials

The Role of Probiotics in HIV Patients With Immunological Non-Responder

PIONIR
Start date: May 7, 2018
Phase: Phase 2
Study type: Interventional

This study will address HIV patients who are on antiretroviral treatment (ART) and experiencing immunological failure. The cause of immunological failure in HIV patients could be due to several factors such as age, gender, Cluster of Differentiation (CD4)+ count before started treatment and some inflammation in the gut. The C-C Chemokine Receptor 5 (CCR5) receptor on T lymphocyte CD4+ are abundantly found in the gut and attacked by HIV virus during acute infection causing irreversible damage. The disruption of gut integrity and chronic inflammation further causing translocation of bacteria in gut lumen to the blood. Thus resulting persistent low CD4+ or immunological failure. This evaluation plan is designed to establish the role of investigation product (probiotics) to improve gut inflammation in HIV patients.

NCT ID: NCT03567174 Completed - HIV/AIDS Clinical Trials

Building on Needle Exchange to Optimize Prevention & Treatment

Start date: June 22, 2018
Phase: N/A
Study type: Interventional

There are several biomedical interventions that can help people who inject drugs (particularly those with or at risk for HIV), but these services often do not get to the people most in need. In this project investigators propose to determine if delivery of these services to PWID by an integrated care van that is linked to a mobile syringe service program improves clinical outcomes, is feasible and sustainable, and is cost-effective.

NCT ID: NCT03565588 Completed - HIV/AIDS Clinical Trials

Manicaland VMMC Uptake Through Behavioural Incentives Trial

Start date: July 7, 2018
Phase: N/A
Study type: Interventional

Primary Objective The purpose of this study is to evaluate the impact of an interactive VMMC education session offered by a circumcised health worker and contribution to transport costs for accessing VMMC along with either (1) conditional economic compensation for wages or (2) lottery-based economic incentives on the uptake of VMMC. Hypothesis VMMC education session offered by a role model - a young male health worker who has been previously benefited from VMMC services in this community - addressing risks of HIV infection, benefits of VMMC, and the fear of pain associated with VMMC, with/without a conditional fixed or lottery-based financial incentives off-setting present-biased preferences, will improve risk perception and increase uptake of VMMC in HIV-negative young men. Study outcomes The primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of men taking up VMMC within 6 months measured through self-reports and matched to program records.

NCT ID: NCT03561103 Completed - Clinical trials for Human Immunodeficiency Virus

Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Client-Centered Representative Payee is a structural intervention that provides financial management support to PLWHA by modifying the implementation of a long-standing policy within the Social Security Administration, in which an organization is authorized to serve as the client's payee. The central hypothesis of this study is that by helping clients to pay rent and other bills on time, housing stability will improve and financial stress will decrease. By reducing the cognitive burden of living with chronic financial stress and frequent threats of housing loss, clients can devote more time and attention to medical appointments and medication adherence. It is further hypothesized that these changes will improve clients' self-efficacy for health behaviors, retention in care, medication adherence, and viral loads. These hypotheses will be tested via the following specific aims: (1) Conduct a randomized controlled trial with two randomized arms (n=160) and two non-randomized arms (n=50) to test the effect of Client-Centered Rep Payee on ART adherence and viral load among PLWHA who are economically disadvantaged and unstably housed. Clinical adherence will be compared through behavioral and biological measures including prescription refill data, self-reported appointment adherence, and viral load for patients receiving the intervention versus those receiving standard of care. (2) Test underlying mechanisms associated with Client-Centered Rep Payee that contribute to changes in medication adherence and viral suppression rates. This will be accomplished via use of quantitative (mediation analysis) and qualitative (semi-structured interview) methods to test hypothesized mediators of medication adherence and viral suppression including financial and housing instability, financial stress, self-efficacy for health behaviors, and retention in care. (3) Assess the cost and cost-effectiveness of the Client-Centered Rep Payee model. An economic analysis will be conducted to model the impact of the intervention as compared with standard of care on quality adjusted life years as well as new infections averted. This approach is innovative because it offers a structural intervention to improve adherence by addressing the effects of economic insecurity, requires low financial investment, and can be layered with existing clinical services. Further, it is highly scalable as it builds on a current policy in practice within the Social Security system.