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People Living With HIV clinical trials

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NCT ID: NCT05362916 Recruiting - Clinical trials for People Living With HIV

Letermovir in ART-treated HIV-infected Persons

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

This is a multi-centre, open-label, randomized, controlled clinical trial to assess the influence of letermovir on gut translocation marker LPS in blood in ART-treated cytomegalovirus (CMV)-seropositive adult people living with HIV (PLWH). The study will explore the influence of letermovir treatment on gut damage, with no intention for label change. Participants (n=60) should have a cluster of differentiation 4 cells (CD4) count greater than 400 cells/µl and a negative viral load. Forty (40) participants will be randomized to receive letermovir (PREVYMIS® 480 mg or 2x240mg orally) in addition to their usual ART, and 20 participants will receive standard of care alone (ART only) for 14 weeks. Study visits will include screening, 2 baselines, followed by follow-up visits at 2 and 4 weeks and at 14 weeks after starting treatment and 12 weeks after end of letermovir treatment to assess a carry-over effect. In an optional sub-study, colonoscopies and colon biopsies will be performed before and after letermovir treatment or standard of care alone to assess gut mucosa inflammation.

NCT ID: NCT05123144 Recruiting - Clinical trials for People Living With HIV

A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago

ORCHID
Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

Among people living with HIV (PLWH), positive affect is uniquely associated with lower levels of depression, slower disease progression, better adherence to medication, and higher likelihood of achieving suppressed viral load, independent of negative affect. In two randomized controlled trials with PLWH (R01 MH084723; R01 DA033854), the investigators have shown significant beneficial effects of an intervention that aims to increase positive affect on viral suppression and psychological well being. The investigators also have demonstrated feasibility, acceptability, and early efficacy of a self-guided, online-delivered, positive affect skills intervention for PLWH (R34 MH101265). Now, in collaboration with the AIDS Foundation of Chicago (AFC), the investigators propose to conduct a Hybrid Type II effectiveness-implementations study of a stepped wedge cluster randomized trial (SW-CRT) of mental health screening and referral to ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery). The proposed study was initiated by AFC, which developed the mental health screening and selected the SW-CRT design as an ethical way to study implementation while ensuring that all clients with elevated depression receive the intervention. Mental health screening + ORCHID will be implemented through all medical case managers (MCMs) at 17 Ryan White-funded clinics in Chicago. The investigators will use the RE-AIM framework to structure the effectiveness and implementation outcomes and the Consolidated Framework for Implementation Research (CFIR) to understand the implementation outcomes at the patient and clinic levels. The specific aims are to: (1) Operationalize an implementation facilitation strategy to link mental health screening with referral to ORCHID through MCMs at Ryan White-funded clinics in Chicago; (2) Determine the effectiveness of screening + ORCHID for improving depression, retention in care, and viral suppression, among 300 PLWH receiving care at 17 Ryan White clinical sites, using a stepped wedge cluster randomized design. Depression is the primary outcome and retention in care and viral suppression at both the individual and clinic level are the secondary outcomes; and (3) Evaluate the implementation of screening + ORCHID and iteratively refine the strategy for subsequent steps. The proposed research holds significant promise for advancing current knowledge on how best to integrate and respond to mental health screening in Ryan White clinics. Data from the hybrid trial will result in a sustainable, scalable program that can be disseminated in Ryan White clinics nationwide, thus holding significant promise for advancing Chicago toward goals in the National Ending the HIV Epidemic Plan.

NCT ID: NCT05085145 Recruiting - COVID-19 Clinical Trials

Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV

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

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.

NCT ID: NCT04684758 Completed - Clinical trials for People Living With HIV

HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study

GANYMEDE
Start date: April 14, 2021
Phase:
Study type: Observational

In France, men who have sex with men (MSM) born abroad are the most affected population by HIV, in terms of HIV incidence and prevalence of undiagnosed infections. Close to 50% of born-abroad HIV-infected MSM are living in the region of Ile-de-France, which is the metropolitan area of Paris. Recent European data, not including France, suggest that born-abroad MSM have the highest rate of post-migration HIV acquisition. Many vulnerability factors could explain le burden of HIV in this group of the population. A better understanding of vulnerability factors related to post-migration HIV acquisition should allow to improve HIV prevention and screening strategies among born-abroad MSM living in France. This, in turn, should reduce the burden of HIV in this population in France.