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HIV-1 Infection clinical trials

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NCT ID: NCT05998499 Completed - HIV-1-infection Clinical Trials

HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort

ELHC
Start date: January 30, 2022
Phase:
Study type: Observational [Patient Registry]

This is a longitudinal observational study conducted in Europe that describes migrants infected with HIV from Latin America who come to Europe with the intention of seeking asylum or international protection. The aim of the study is to identify the barriers this population faces in accessing the healthcare system and to assess disease control

NCT ID: NCT05634265 Completed - Depression Clinical Trials

Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study

Start date: January 31, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.

NCT ID: NCT05606055 Completed - HIV-1-infection Clinical Trials

The Benefits of Immediate Treatment Initiation Without Immunovirological Data Compared to Conventional BIC / FTC / TAF Treatment in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection

Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data ("Same Day Treatment") compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV (human immunodeficiency virus) infection

NCT ID: NCT05495204 Completed - HIV-1-infection Clinical Trials

External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Start date: August 5, 2022
Phase:
Study type: Observational

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

NCT ID: NCT05481216 Completed - COVID-19 Clinical Trials

HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV

HIV CoCo
Start date: March 29, 2022
Phase:
Study type: Observational

HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected with the SARS-CoV-2 coronavirus. The study will address two central questions: 1. Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases? 2. Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course? The study will address these questions by recruiting patients co-infected with both HIV and SARS-CoV-2 and comparing them to two control groups - one group infected with SARS-CoV-2 only and another group infected with HIV only. Only deidentified, real-world retrospective data will be used for the study, collected as part of standard, routine clinical care. Additionally, this study will also look to: 1. Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls 2. Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy 3. Describe the co-morbidities in PLWHIV and controls with COVID-19 4. Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission. Data will be collected about patient outcomes from COVID-19 (including hospitalisation for COVID-19, length of stay in hospital, critical care admission, ventilation/oxygenation requirements, and need for kidney replacement therapy), as well as pre-existing health conditions, and relevant blood results at COVID-19 diagnosis.

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: NCT05351684 Completed - HIV-1-infection Clinical Trials

Effect of Dolutegravir Intensification on HIV-1 Reservoirs

EDIT
Start date: January 1, 2019
Phase: Phase 2
Study type: Interventional

Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal. The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.

NCT ID: NCT05349838 Completed - HIV-1-infection Clinical Trials

An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTIs Resistance Mutation K103N

WISARD
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted PI-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients. The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg OD + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus. In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

NCT ID: NCT05306704 Completed - HIV-1-infection Clinical Trials

High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial

HDVDS-HIVT
Start date: February 15, 2019
Phase: Phase 3
Study type: Interventional

High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.

NCT ID: NCT05243602 Completed - HIV-1-infection Clinical Trials

BFTAF Elderly Switch Study

BFTAF
Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

BACKGROUND: Current Kenya National Anti-retroviral (ARV) Guidelines and World Health Organization (WHO) Guidelines recommend first-line therapy of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG) for adult people living with HIV (PLHIV). This regimen has limitations, particularly for the aging PLHIV who are more likely to have pre-existing comorbidities and higher risk of developing comorbidities, including osteopenia, osteoporosis, and renal insufficiency. Abacavir, the preferred alternative nucleoside reverse transcriptase inhibitor (NRTI) in Kenya, is associated with increased cardiovascular risk that also limits its use in elderly populations. B/F/TAF is highly efficacious, well tolerated, co-formulated in a small pill, and does not have the same bone, renal or cardiovascular risks associated with currently recommended regimens in Kenya. We are not aware of any clinical trial to date that has been fully powered to compare ARV regimens for the increasing population of elderly PLHIV. BROAD OBJECTIVE: We will compare the efficacy, safety, and impact on bone mineral density of switching to B/F/TAF to that of remaining on current ARV regimen in a population of elderly patients (60 years old or greater) with no prior confirmed treatment failure in Kenya.