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HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

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NCT ID: NCT05471076 Active, not recruiting - HIV-1-infection Clinical Trials

Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b Adjuvanted With 3M-052-AF + Alum in Healthy, HIV-1 Uninfected Adult Participants

Start date: August 22, 2022
Phase: Phase 1
Study type: Interventional

The clinical study is designed to evaluate the ability of two priming vaccine regimens to activate and induce the maturation of cross-reactive CD4 binding site (CD4-bs) antibodies, including VRC01-class antibodies. VRC01- class antibodies are highly desirable to elicit via vaccination because they have broad cover all clades of HIV and passive administration of VRC01 monoclonal antibodies has been demonstrated to prevent acquisition of susceptible HIV strains in clinical trials. The study will assess whether B cells expressing VRC01-like B cell receptors proliferate following immunization with a 'germline-targeting' recombinant Env immunogen. The study will also test whether an immunization strategy based upon fractionated dose delivery of the immunogen may improve the maturation of VRC01-class B cells when compared to traditional bolus dosing. In addition, the study will test whether alterations in the dose of the subsequent boost immunizations affects VRC01-class B cell activation and the rate of antibody affinity maturation.

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: NCT05433987 Not yet recruiting - HIV-1-infection Clinical Trials

Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy

LONGADAPT
Start date: July 2022
Phase:
Study type: Observational

The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients

NCT ID: NCT05421286 Not yet recruiting - Inflammation Clinical Trials

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

MISTRAL
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2024. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

NCT ID: NCT05418790 Not yet recruiting - HIV-1-infection Clinical Trials

A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy

Start date: July 2022
Phase: N/A
Study type: Interventional

A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.

NCT ID: NCT05414786 Active, not recruiting - HIV-1-infection Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644)

Start date: May 25, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.

NCT ID: NCT05411237 Not yet recruiting - HIV-1-infection Clinical Trials

Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma

Start date: March 15, 2024
Phase: Phase 3
Study type: Interventional

This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.

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: NCT05383456 Completed - HIV Clinical Trials

The Visceral Adiposity Measurement and Observation Study

VAMOS
Start date: April 18, 2022
Phase:
Study type: Observational

The Visceral Adiposity Measurement and Observation Study

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.