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HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

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NCT ID: NCT05459077 Recruiting - Hypertension Clinical Trials

Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. An important contributing factor for insufficient blood pressure control is non-adherence to antihypertensive medications. Research on medication adherence for PWH has largely focused on antiretroviral therapy adherence with limited focus on adherence to other non-AIDS condition medications. With a large proportion of PWH in the U.S. achieving viral suppression, providers may now have an opportunity to focus on the management of non-AIDS conditions like hypertension. However, because PWH who have achieved suppression have reduced clinic encounters (once or twice a year) there is potential loss of opportunity to effectively monitor and intensify hypertension treatment as needed an important opportunity to focus on preventing cardiovascular disease. CVD and other non-AIDS comorbidities. The study's overarching goal is to improve the hypertension outcomes for PWH on suppressive ART to reduce cardiovascular disease risk. In this study, we will identify and evaluate healthcare and patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for PWH who have achieved viral suppression. We will use these factors to tailor an intervention and assess the feasibility and acceptability at the Duke ID clinic.

NCT ID: NCT05405582 Recruiting - HIV-1-infection Clinical Trials

Thetha Nami Ngithethe Nawe ("Let's Talk"): Step Wedge cRCT of Peer Led Community PrEP and SRH for Youth in South Africa

Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Study Hypothesis: Social mobilisation will attract and engage young people into decentralised sexual reproductive health (SRH) services where HIV prevention is tailored to need. Decentralised risk informed (differentiated) biosocial HIV prevention will reduce the overall prevalence of sexually transmissible HIV amongst young people aged 15-30. Study aims: 1. Measure the impact of social mobilisation into decentralised SRH services that provide tailored HIV prevention on the prevalence of transmissible HIV. 2. Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRH with tailored HIV prevention to deliver differentiated biosocial HIV prevention. Study design: A step-wedge cluster randomised control trial comparing the effect of the Intervention (social mobilisation by peer navigators into mobile nurse-led SRH clinics) with Standard of Care (SoC) at Primary Health Care clinics, in reducing the proportion of 15-30 year olds with sexually transmissible HIV and increased uptake of risk-informed (differentiated) HIV prevention Intervention: Peer navigator social mobilisation intervention includes safe spaces, structured psychosocial and health needs assessment; Peer-mentorship with tailored health promotion, psychosocial support and lay-counselling; provision of condoms, HIV self-tests and pregnancy tests. The mobile SRH clinics provide sexually transmitted infection (STI) care, contraception, HIV testing and antiretroviral therapy (ART) if positive and Pre-Exposure Prophylaxis (PrEP) for those eligible (based on national guidelines) and negative. SoC at Primary Health care clinics includes, contraception, HIV testing and ART if positive and PrEP for those eligible and negative. Population: The eligible population are ~26,000 15-30-year-old residing in 40 administrative areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal. The 40 clusters will undergo a stratified randomisation to early versus delayed intervention roll out. Data collection: Research data will be collected from four sources: i) three random representative surveys of n= 2000, 15-30-year-olds; ii) programme, process, and clinical data; iii) qualitative data collected during the process evaluation iv) cost data using bottom-up ingredient-based costing and top-down costing using the budgets and expenditure reports. Study Duration: 36 months.

NCT ID: NCT05381844 Recruiting - HIV-1-infection Clinical Trials

Quantification of Antisense HIV RNA in Patients

Start date: October 20, 2022
Phase:
Study type: Observational

The objective of this study is to quantify the expression levels of the HIV-1 unspliced sense transcript and of total HIV-1 antisense transcripts in PBMCs of HIV-1-infected persons, either still untreated or virologically controlled on treatment, and to investigate their correlations with the HIV reservoir as assessed by the quantification of total and integrated HIV-1 DNA.

NCT ID: NCT05374109 Recruiting - HIV-1-infection Clinical Trials

SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

NCT ID: NCT05330143 Recruiting - HIV Infections Clinical Trials

Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

Start date: June 28, 2022
Phase: Phase 2
Study type: Interventional

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.

NCT ID: NCT05275998 Recruiting - HIV-1-infection Clinical Trials

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

Start date: July 5, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test various doses of the combination of the antibodies for safety and pharmacokinetics in suppressed subjects on cART. Once dosing is established based on safety and PK, the optimally dosed combinations will be assessed as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 24 weeks.

NCT ID: NCT05220358 Recruiting - HIV-1-infection Clinical Trials

Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study

Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

The RECOVER study is a self-controlled case series to evaluate whether the addition of Fostemsavir (Rukobia) to a stable HIV regimen in virologically suppressed patients living with HIV who never experience optimal CD4 T-cell count recovery can result in meaningful increases in different immunologic parameters such as CD4 T-cell count, CD4 T-cell percentage and CD4/CD8 ratio

NCT ID: NCT05215704 Recruiting - HIV Infections Clinical Trials

Ex Vivo Characterization and Targeting of the Latent HIV Infected Reservoir to Cure HIV

EX VIVO
Start date: January 1, 2012
Phase:
Study type: Observational

Combination antiretroviral therapy (cART) blocks intracellular human immunodeficiency virus (HIV) replication in CD4+ T-lymphocytes, but fails to eliminate latent HIV infected CD4+ T-lymphocytes. About 7 (range <1-100) in 106 of these cells are latently infected and can cause reactivation of proviral HIV when cART is stopped. These latently infected cells form the reservoir and must be targeted in order to cure HIV. We would like to further investigate this reservoir and assess potential interventions to eradicate it. One promising option is to further study the influence of HIV latency disruptors (latency reversing agents, LRA) on the HIV infected reservoir. These agents are used in shock and kill strategies that disrupt latency by LRA followed by the selective (induced) killing of the reservoir cell due to viro-pathogenic effects. For accurate assessment of the reservoir and potential cure strategies, including the impact of LRA on the reservoir, a large reservoir and sufficient cells for analysis are desirable. Our understanding on the reservoir comes from in vitro lymphocyte models and early ex vivo studies. Additional studies of patients with different clinical phenotypes including untreated versus treated versus the rare individuals that control HIV spontaneously are increasingly relevant to the field. Especially this last category represent biological examples of viral control without cART and are useful to study the factors that set them apart from those that need treatment for their HIV. This study aims to deepen our understanding of the HIV reservoir and cure strategies, foremost, shock and kill strategies. We will do this by setting up a durable ex vivo platform for HIV reservoir and cure studies of which the samples can be used for hypothesis generation for in-vivo studies. A project from the Erasmus MC HIV Eradication Group (EHEG).

NCT ID: NCT05147740 Recruiting - HIV-1-infection Clinical Trials

Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

Start date: July 1, 2021
Phase: Phase 4
Study type: Interventional

To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.

NCT ID: NCT05140876 Recruiting - HIV-1-infection Clinical Trials

Supporting Treatment Adherence for Resilience and Thriving (START)

START
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.