HIV - Human Immunodeficiency Virus

The purpose of this trial is to evaluate the immunomodulatory effects of glatiramer acetate (GA) in improving the recovery of CD4 T cells and the CD4/CD8 ratio in people living with HIV (PLWHIV) who have poor immune recovery and persistent immune activation, despite virologically effective antiretroviral (ARV) treatment. ANRS 0766s GEODE is a Pilot, multicenter, randomised and open-label clinical trial: Participants will be randomized 2:1 to either one of the two parallel arms * Arm A (24 participants) : Glatiramer Acetate (GA) * Arms B (12 participants) : control Randomisation of the trial arms: The participants will be randomised in an open-label trial in a 2:1 ratio with, for each arm, a distribution by age group (\< 50 and = or \> 50 years) using a minimisation randomisation method. The trial will consist of three phases: Phase I: A first controlled phase in which participants in arm A will receive subcutaneous injections of GA three times a week for 16 weeks, and will be compared with participants randomised to arm B who do not receive GA (control group). The primary endpoint will be assessed at week 16 (end of the controlled phase). Phase II: A second post-interventional observational phase will begin after W16 to evaluate a potential post-treatment effect and its duration in arm A. During this phase, the efficacy of the strategy during the phase I will be analysed for all participants (once the last randomised participant has reached week 16). It will continue until the potential opening of the phase III extension, in the event of efficacy be confirmed, or until the decision to terminate the trial if this is not the case. Phase III: An optional third extension phase may be offered to participants in both arms. The opening of this phase will be conditional upon prior demonstration of a global benefit between both treatment groups during Phase I. During this optional phase III, participants in arm A will be offered a second cycle of GA and those in arm B, a first cycle of GA at the same frequency as a subcutaneous injection three times a week for 16 weeks. Participation in this phase will be optional. All participants will continue their current antiretroviral treatment.

Community pharmacies (CPs) have emerged as promising differentiated service delivery models for refilling antiretroviral therapy (ART) among people with human immunodeficiency virus (HIV). Documented benefits of CP-based refills include improved treatment adherence and viral suppression, reduced healthcare provider workload, and reduced facility congestion. This trial will evaluate the acceptability, feasibility, fidelity, and preliminary effectiveness of integrating TB treatment into CPs among people with TB/HIV in Kampala, Uganda.

Study Summary: OLEUM VIHTAEGeneral Information Sponsor: Fundación SEIMC - GESIDA Study Title: Effect of Extra Virgin Olive Oil (EVOO) consumption on the occurrence of cardiovascular events in people living with HIV. Protocol Code: GESIDA 12725 (Version 2.0, Jan 13, 2026) Study Design: National, multicenter, randomized, open-label clinical trial. Intervention Product: Extra Virgin Olive Oil (EVOO). Estimated Enrollment: 1,324 participants (662 per arm). Study Duration: Approximately 60 months (5 years) per participant. Objectives Primary Objective: To analyze the incidence of a composite index of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), including acute coronary syndrome, peripheral arterial disease, coronary/cerebral/peripheral revascularization, cerebrovascular disease, and cardiovascular or cerebrovascular death. Secondary Objectives: Incidence of individual cardiovascular events (Stroke, TIA, Heart Failure, Atrial Fibrillation). All-cause and cardiovascular mortality. Changes in metabolic and physical parameters (weight, blood pressure, glucose, lipid profile). Development of new comorbidities (HTA, DM2, Obesity) and initiation of related treatments. Exploratory sub-studies: Changes in gut microbiota, epigenetic aging markers, inflammation panels (96 cytokines), and urinary hydroxytyrosol levels. Study Population Key Inclusion Criteria: HIV-1 infected individuals (diagnosed ≥ 1 year). Age: 50 to 75 years. On Antiretroviral Therapy (ART) ≥ 1 year with suppressed viral load (\<50 copies/mL) for at least 6 months. Presence of at least one cardiovascular risk factor (HTA, DM2, high LDL, low HDL, smoking, or family history). Willingness to modify diet and no intolerance to EVOO. Key Exclusion Criteria: Pre-existing ischemic heart disease, cerebrovascular disease, or peripheral arterial disease. Calculated cardiovascular risk (RV10 ASCVD) \< 5%. Life expectancy \< 1 year or inability to complete the study. Severe comorbidities: Stage C Cirrhosis, end-stage renal failure, dementia, or active malignancy. Current high EVOO intake (≥30 mL/daily). Treatment Plan Participants will be randomized (1:1 ratio) into two groups: EVOO Group: Daily intake of 50 mL of Extra Virgin Olive Oil. Control Group: Continuation of their usual diet (verified as not rich in EVOO). Statistical Analysis \& Monitoring Primary Endpoint: Proportion of patients meeting the composite cardiovascular morbidity/mortality index at 5 years. Methodology: Analysis by protocol and intention-to-treat (ITT) using SPSS v28. Generalized linear models for repeated measures, adjusted for covariates. Interim Analysis: Planned for Year 2 and Year 4. Ethics Board (Board Affiliation): CEIm Hospital Costa del Sol, Marbella, Spain.

Migrants living with HIV - whether the infection was diagnosed in their country of origin or in France- frequently experience vulnerabilities related to their migration trajectories and often face socioeconomic and administrative instability upon arrival . The primary outcome of this study is to compare the immunovirological efficacy of antiretroviral therapy among migrants living with HIV patients according to their social and administrative status.

The risk of atherosclerotic cardiovascular disease is increased in people with HIV infection, including young patients and those with few traditional cardiovascular risk factors. The increased risk of cardiovascular disease among people living with HIV is due to accelerated atherosclerosis, caused by chronic inflammation and immune dysregulation. The measurement of coronary calcium using plain computed tomography is a subclinical indicator of coronary atherosclerosis and is associated with the risk of cardiovascular events and mortality in the general population.

Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.

Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from pregnant women attending antenatal care (ANC) services in the Democratic Republic of the Congo. This study aligns with the WHO 2022-2030 strategy for the integrated elimination of mother-to-child transmission of HIV, HBV, HCV, and syphilis.

The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest / acceptability of long-lasting injectable options for human immunodeficiency virus (HIV) prevention.

Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat \>20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.