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HIV clinical trials

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NCT ID: NCT03670316 Not yet recruiting - HIV Clinical Trials

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

NCT ID: NCT03663920 Recruiting - HIV Clinical Trials

HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

INAPROACTIVE
Start date: January 9, 2018
Phase:
Study type: Observational

INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. All participants will be managed according to the Indonesian HIV/AIDS Treatment Guideline and/or the Standard of Care (SoC) in local clinical setting, with the addition of rapid HIV viral load, CD4 cell count and syphilis testing.

NCT ID: NCT03656783 Not yet recruiting - HIV Clinical Trials

Effects of Biktarvy on CFR in Stable HIV Patients

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.

NCT ID: NCT03649607 Not yet recruiting - HIV Clinical Trials

Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black

Start date: September 2018
Phase: N/A
Study type: Interventional

Nearly two-thirds of ACB people living in Ontario are classified as immigrant, refugee or undocumented [non-status/NS] (IRNS) individuals. IRNS people are more likely than the general population to be exposed to events that are associated with posttraumatic stress disorder (PTSD). Furthermore, the diagnosis of HIV is itself a traumatic life event. Nonetheless, significant gaps remain regarding the best strategies for supporting trauma-informed care among ACB IRNS individuals with HIV. Accelerated Resolution Therapy (ARTh) is an exposure-based therapy that incorporates rapid eye movements in a standardized administration over 1-5 sessions. ARTh is an effective brief treatment for PTSD symptoms; but, it's range of therapeutic benefit when applied to people with co-morbid HIV infections is unknown. No studies have leveraged neuroimaging to validate the self-reported empirical therapeutic benefit of ARTh. The investigators propose to investigate the implementation of ARTh, including understanding factors influencing its therapeutic outcomes. The three specific aims of this study are to (1) identify factors influencing the response to ARTh (2) identity neuroimaging indicators for treatment effects of ARTh, and (3) to identify factors influencing ARTh implementation. The investigators will conduct a pre-/post- evaluation of intervention outcomes of ARTh implemented in a sample (n=40) of HIV-positive ACB IRNS ages 18-45 years (Aim 1). The investigators will use statistical analyses to identify factors that may moderate the treatment response of ARTh on PTSD symptoms, HIV symptoms distress and quality of life (Aim 1). The investigators will use diffusion tensor imaging and resting state functional magnetic resonance imaging (fMRI) metrics to assess structural and functional connectivity and examine their associations with PTSD symptoms and HIV symptom distress (Aim 2). Finally, the investigators will use process measures to study two specific implementation factors (acceptability and appropriateness) regarding ARTh use in this population. As a consequence of this research, the investigators expect to generate data that will be used to refine an ARTh implementation protocol that will be integrated into an adaptive implementation trial to reduce gaps in the HIV care continuum through the use of intervention packages for ACB people customized to the individual's needs.

NCT ID: NCT03645044 Recruiting - Hiv Clinical Trials

Towards a Functional Cure for HBV - The COMMIT Cohort Study

COMMIT
Start date: May 24, 2018
Phase:
Study type: Observational

Hepatitis B virus (HBV) infection can be treated, but therapy is usually lifelong and has side effects, so a cure for HBV is a critical endpoint. This study examines the key steps to HBV cure in the setting of HIV-HBV co-infection, where rates of development of antibodies against HBV after starting HBV treatment are higher than in people with HBV alone starting treatment. In Asia both HBV and HIV are common so this provides a unique opportunity to study HBV. We will investigate how an effective immune response against the two main HBV proteins is developed. If we can understand how the immune response works against HBV, this could be used to develop new therapies towards a cure for HBV

NCT ID: NCT03640923 Not yet recruiting - Hiv Clinical Trials

Germinal Transmission After Endogenization of HIV Sequences Without a Competent Virus for Replication and a Potential Protective Role

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

It is necessary to better understand the transmission of human immunodeficiency virus (HIV) genome sequences by gametes without replication-competent virus transmission. In fact, HIV endogenization could be protective. Some studies are supporting this hypothesis, one shew the presence of HIV genome sequences in spermatozoa, and others show that HIV-positive "Elite controllers" patients have HIV genome sequences without a replication competent virus. One study found HIV genome sequences without a replication-competent virus in the cells of an HIV-negative child whose mother is a non-sick HIV-positive. We will conduct a prospective descriptive and analytical study over a period of 2 years, from September 2018 to November 2020. We will explore by FISH method in the IHU Méditerranée-Infection laboratory, Marseille, the presence or absence of HIV genome sequences without a replication-competent virus in epithelial cells of children with parents are infected by HIV. Children included must be under 12 months of age, followed at Robert Debré Hospital, Paris or Timone Enfant Hospital, Marseille because of a parental HIV infection. They must have the recommended blood tests to assess their HIV status and the parents consent should be written. Subsequent progression to HIV infection or not will be followed and a statistical study will be conducted to establish a link between the presence of endogenized HIV genome sequences in epithelial cells and the developpement or not of HIV infection.

NCT ID: NCT03633721 Not yet recruiting - HIV Clinical Trials

Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women

Start date: November 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to try to understand and explain why HIV-infected and uninfected women who use cannabis (marijuana) currently, or have used cannabis in the past, have higher risk of having experienced a fall in our earlier analyses in WIHS. This study will compare what happens when women are given cannabis compared with placebo, on measures of mobility, including walking speed under walking conditions that vary in terms of difficulty; for example normal walking and walking while reciting alternate letters of the alphabet, as well as measures of balance and cognition (for example attention, memory).

NCT ID: NCT03629327 Not yet recruiting - Hiv Clinical Trials

Inducing Immune Quiescence the Genital Tract With ASA

IIQ-2
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

There are 33.4 million individuals living with HIV/AIDS worldwide. Despite successful HIV prevention strategies such as condom use and reduction of sexual partners, HIV continues to spread at an alarming rate. In 2010, 2.6 millions of new infections were detected. In Sub-Saharan Africa, women represent the two-third of all new infections1. Despite the efforts of the scientific community, there is still no commercial vaccine or microbicide available. To explain this natural protection against HIV, different mechanisms have been identified. These women have a unique immune phenotype that we called Immune Quiescence. This phenotype is characterized by lower expression of genes involved in cellular activation, lower resting levels of inflammatory cytokine production, lower level of systemic activated T cells, increased levels of systemic T regulatory, increased production of anti-viral anti-protease serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+ CCR5+ T cells) in the FGT This project aims to induce an Immune Quiescence phenotype (decreasing immune activation) to prevent HIV infection

NCT ID: NCT03628287 Recruiting - Hiv Clinical Trials

Program Refinements to Optimize Model Impact and Scalability Based on Evidence

PROMISE
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

In New York, the achievement of 90-90-90 goals is jeopardized not by limited access to affordable care and treatment, but by persistent disparities in HIV viral suppression (VS). Complex behavioral and structural barriers to achieving and maintaining VS require coordinated, combination approaches to meet medical and social service needs. In 2009, at 28 Ryan White Part A (RWPA)-funded agencies, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) launched a multi-component HIV Care Coordination Program (CCP) directed toward the most vulnerable, high-need persons living with HIV (PLWH) in NYC. A systematic CCP effectiveness study began in 2013 (R01 MH101028; PIs: Irvine, Nash). Findings to date suggest that the CCP is superior to usual care for high-need subgroups of PLWH, but there remains substantial room for improvement in short- and long-term VS. In an immediate evidence-to-practice feedback loop, the DOHMH is implementing a refined CCP model in 2018. Greater focusing, tailoring and cues for delivery of key components are expected to increase CCP engagement, reach, fidelity, scalability, effectiveness and impact. The aim of the proposed study is to estimate the effect of the revised (vs. original) CCP on timely VS (within 4 months of enrollment), using experimental methods.

NCT ID: NCT03618862 Not yet recruiting - Hiv Clinical Trials

Study of the Effects of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent Provirus

FXReservoir
Start date: September 2018
Phase:
Study type: Observational

The Farnesoid X receptor (FXR) is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism. A recent study opens the hypothesis that Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes. This hypothesis implied that modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus replication. The results of in vitro studies with Human Immunodeficiency Virus-infected cell lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death; the overall effect is therefore antiviral. Farnesoid X receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies. This last data raises the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus. It is therefore crucial to confirm on quiescent CD4 + T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models. Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome. The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains. It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 + T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART. Human Immunodeficiency Virus-positive patients will be any patients, irrespective of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of antiretrovirals, away from primary infection, when they already had a complete western blot, indicating an evolution of the infection without treatment and constitution of an already evolved reservoir. Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 + T lymphocytes / mm3.