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HIV Infection clinical trials

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NCT ID: NCT06421259 Not yet recruiting - Hiv Infection Clinical Trials

Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.

Start date: May 20, 2024
Phase:
Study type: Observational

In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.

NCT ID: NCT06200545 Enrolling by invitation - HIV Infection Clinical Trials

Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi

NJIRA
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual cisgender men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.

NCT ID: NCT06019273 Recruiting - HIV Infection Clinical Trials

Impacts of Different ART Regimens on Lipid Metabolism in People Living With HIV

ART
Start date: April 25, 2022
Phase:
Study type: Observational [Patient Registry]

To compare the dynamic changes of lipid metabolism of people living HIV who treated with different antiretroviral therapy (ART) regimens such as Biktarvy EVG/c/TAF/FTC, DTG/FTC/TDF, TDF/3TC/EFV, etc. And to assess the safety and efficacy of different antiretroviral therapy.

NCT ID: NCT05993767 Not yet recruiting - HIV Infection Clinical Trials

UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

UNIVERSAL1
Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.

NCT ID: NCT05965245 Recruiting - Depression Clinical Trials

Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth

Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.

NCT ID: NCT05766501 Active, not recruiting - HIV Infection Clinical Trials

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Start date: March 17, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

NCT ID: NCT05663502 Recruiting - Lymphoma Clinical Trials

Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers

Start date: May 10, 2023
Phase:
Study type: Observational

This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.

NCT ID: NCT05652088 Enrolling by invitation - HIV Infection Clinical Trials

The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection

Start date: March 14, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to understand the effects of HIV cure strategies on the virus and immune cells that reside within the gastrointestinal tract. Subjects receiving therapies with the potential for HIV cure will undergo a colonoscopy to obtain gastrointestinal tissue for research assays. This study will test whether receiving these therapies will induce changes in the immune cells in the gastrointestinal tract and reduce the tissue-associated HIV viral levels.

NCT ID: NCT05633927 Active, not recruiting - HIV Infection Clinical Trials

Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed

Start date: April 1, 2021
Phase:
Study type: Observational

Prospective, non-equality, cohort study, where investigators propose to analyze humoral and cellular immunity after two doses of SARS-CoV-2 RNA vaccines in HIV-infected participants severely immunosuppressed. A total of 92 HIV-infected subjects over 18 years old with ≤200 CD4/μl (experimental group; n=46) and ≥ 350 CD4/μl (as control group; n=46) who have completed two doses vaccination against SARS-CoV-2 will be included in the study. Primary Objectives: - To analyze the percentage of participants with SARS-CoV-2-specific IgG after 1, 6, and 12 months after vaccination in subjects with ≤200 vs ≥350 CD4/μL by electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2. Roche Diagnostics). - To analyze the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2 after 1, 6, and 12 months after vaccination with <200 vs ≥350 CD4/μL. Multiparametric flow cytometry in peripheral blood mononuclear cells (PBMCs) will be performed to detect the production of cytokines (IL-2, TNF-α and IFN-γ), cytolytic (perforin and granzyme B) and degranulation (CD107a) molecules from T cells, as well as to identify memory B cells specific to SARS-CoV-2 IgG+. Secondary Objectives: To analyze in participants with <200 vs ≥350 CD4/μl after 1, 6, and 12 months after vaccination: - Quantification of specific IgG titers against SARS-CoV-2 - The association of the T response to SARS-CoV-2 with humoral response parameters. - The association of the T response against SARS-CoV-2 with other parameters of immune activation, inflammation and immunosenescence. The phenotypes of maturation (CD45RA and CD27), activation (HLA-DR and CD38), senescence (CD57+CD28-) and markers of immune exhaustion (TIGIT, LAG-3, TIM-3 and PD-1) in CD4 and CD8 lymphocytes T will be determined by multiparametric flow cytometry.

NCT ID: NCT05592613 Active, not recruiting - HIV Infection Clinical Trials

Next Generation Ingestible Sensors for Medication Adherence Measurement

NextGen
Start date: February 20, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.