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HIV Infections clinical trials

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NCT ID: NCT05700734 Not yet recruiting - HIV-1 Clinical Trials

MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)

Start date: April 17, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.

NCT ID: NCT05697289 Not yet recruiting - HIV Infections Clinical Trials

Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy

CABORI
Start date: January 2023
Phase:
Study type: Observational

Question arises as to whether this new treatment "Cabotegravir-rilpivirineactually" improves patient satisfaction and whether it is well suited to everyone, especially those with a history of irregular follow-up. Also, inconvenience of two intramuscular injections every two months and constraint of care organization could represent a barrier to treatment for some patients.

NCT ID: NCT05692505 Not yet recruiting - HIV Infections Clinical Trials

Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Start date: April 1, 2023
Phase:
Study type: Observational

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

NCT ID: NCT05690607 Not yet recruiting - HIV Infections Clinical Trials

Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B (TINIES for BBVs)

TINIES
Start date: January 23, 2023
Phase:
Study type: Observational

During the Covid-19 pandemic era, patients indicated that they find a model of care incorporating remote consultations to be acceptable [1-3]. Remote accessibility to care can be enhanced by using new technology to allow small volume testing for routine blood samples. This study aims to prospectively validate the use of small volume blood sampling for routine HIV-1 and Hepatitis B Virus (HBV) viral load (VL), liver function tests (LFTs) and creatinine, and assess the acceptability of this method of blood sampling to people living with HIV (PLWH). These tests form the usual minimum required for safe monitoring on a routine basis to determine viral activity, liver and renal function in patients either on or off antiviral therapy. The UK based Doctors Laboratory TINIES small volume blood testing kits comprise microcontainers manufactured by BD Diagnostics designed for sample collection from skin puncture, along with home testing pack with lancets, instructions and Royal Mail postal packs. We will collect TINIES samples alongside routine venepuncture samples in people attending their routine clinic follow ups. We will then send kits to different participants to collect samples in their own home, along with a follow up questionnaire (written/online). Finally, we will conduct a more in-depth telephone interview for a subset of patients to qualitatively assess acceptability. Routine use of this method of testing could revolutionise care of people living with chronic blood borne viruses, for example HIV and chronic HBV. TINIES could enable remote monitoring, increasing ease of access to care, reducing clinic appointment burden in otherwise healthy individuals, and reduce labour costs in the NHS, for example, by reducing phlebotomy appointments.

NCT ID: NCT05687565 Recruiting - HIV Infections Clinical Trials

Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV

FATHIV
Start date: September 27, 2022
Phase: N/A
Study type: Interventional

Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity. Design: Pilot, randomized, placebo-controlled, patient-blind study. Patients ≥18 years old with HIV-1 receiving stable ART (no change in ART for at least 6 months) and a serum HIV RNA load of < 50 RNA copies/mL for at least 2 years and with a CD4 T cell count >300 cells/μl will be randomized 1:1:1 to dietary supplementation with placebo (controlled group) or lauric acid 1.5 g once daily (experimental group 1) or with lauric acid 3 g once daily (experimental group 2) for 24 consecutive weeks. Primary objective: To assess the effect of dietary lauric acid supplementation, compared with placebo, on the reactivation of HIV transcription in latently infected CD4 T cells in HIV-infected patients on suppressive antiretroviral therapy.

NCT ID: NCT05685641 Not yet recruiting - Clinical trials for Acquired Immunodeficiency Syndrome

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

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

In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.

NCT ID: NCT05680948 Not yet recruiting - HIV Infections Clinical Trials

Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020)

T003EFUP2020
Start date: January 2023
Phase:
Study type: Observational

A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

NCT ID: NCT05674682 Completed - HIV Infections Clinical Trials

Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study

Seroincidence
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

PrEP (pre-exposure prophylaxis) is an effective prevention strategy in which HIV-negative individuals take antiretroviral drugs (tenofovir disoproxil fumarate and emtricitabine - TDF/FTC) to reduce HIV acquisition. Clinical studies have shown that the TDF/FTC combination protects MSM and transgender women against HIV infection. According to the PROUD study, PrEP can decrease the risk of HIV infection among MSM by 86% (90% CI 64-96). The international community recognizes that PrEP can be an additional tool in the framework of a combination prevention package for those most at risk of contracting HIV. Data on HIV incidence among MSM and trans women are largely unknown. In Brazil, Mexico and Peru, data on the incidence of HIV among MSM and trans women are very scarce, limited to small cross-sectional studies.Current methods used to determine HIV-1 incidence have many limitations. These methods include mathematical modeling, retrospective calculations of AIDS case reports, age-based prevalence determinations, and prevalence determinations with multiple rounds of longitudinal surveys to estimate HIV incidence, which require numerous assumptions and inputs and can pose additional challenges in the era of expansion of antiretroviral therapy (ART) and increased survival of HIV-1 infected individuals. On the other hand, prospective longitudinal cohort studies of high-risk individuals can be used to estimate incidence; however, they are often labor-intensive, complex, very expensive, difficult to implement in most countries, and have recruitment biases. Laboratory methods can be unbiased and do not require complicated assumptions and case-by-case weighting. The cross-sectional use of Recent HIV Infection Tests (TRIs) based on biomarkers offers, in principle, accessible, reliable and low risk of bias options for estimating incidence.

NCT ID: NCT05674656 Not yet recruiting - HIV Infections Clinical Trials

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Start date: February 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).

NCT ID: NCT05668780 Not yet recruiting - HIV Infections Clinical Trials

Buprenorphine Integration Research and Community Health

BIRCH
Start date: January 22, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate an intervention strategy in introducing screen/evaluate/treat (SET) procedures for HIV/ hepatitis C/ and Opioid Use Disorder in Primary Care Clinics in West Virginia. The main questions it aims to answer are: - What are the barriers and facilitators to integrating evidence based practices for screening and treatment of HIV, hepatitis C, and Opioid Use Disorder into primary care clinics in West Virginia? - To assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx (formerly known as Network for the Improvement of Addiction Treatment) facilitation and Extension for Community Healthcare Outcomes (ECHO)-supported collaborative learning? - Does implementing these services improve primary and secondary health outcomes for patients? Primary Care Clinics will participate in training and process improvement coaching to integrate these services. Using a step-wise design, 20 Primary Care Clinics will undergo the training and coaching in four groups of five clinics.