Active clinical trials for "HIV Infections"

Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads.

Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.

Various facts support the study of COVID-19 vaccine immunogenicity in People Living With HIV (PLWH) at this time: (1) Many PLWH in Canada will be eligible to receive COVID-19 vaccination as they are in a high priority risk group, such as residents or staff of shared living facilities for seniors, health care workers with direct patient contact, aged 70 years of age or older, or adults in Indigenous communities; (2) As vaccines against many other pathogens, it is plausible that the current standard vaccination strategy of COVID-19 is less effective in PLWH; (3) The potential burden of significant COVID-19 infection in PLWH is likely large given many PLWH are aging and have co-morbidities known to predispose to worse COVID-19 outcomes; (4) The vaccine clinical trials which include PLWH63, have stringent exclusion criteria, making results non-generalizable to many PLWH such as those with lower CD4 counts. With the rapid roll-out of COVID-19 vaccination, many PLWH will be receiving the COVID-19 vaccine. Through vaccination, the provision of the same dosage of antigen stimulation to all individuals will result in a controlled method to measure immune response in PLWH. Therefore, we propose to develop a pan-Canadian cohort of PLWH receiving a COVID-19 vaccine(s) to assess a spectrum of immune responses. We also aim to assess the safety and tolerability of the COVID-19 vaccines in PLWH. These data may provide support for the use of one vaccine product over another and for exploring alternate vaccination strategies in PLWH (i.e., increased dose or double-dose vaccination and so forth).

Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. High quality paediatric HIV care requires routine monitoring of clinical and virologic status, support for ART adherence, and patient outreach to optimize retention in care. The HIV Infant Tracking System (HITSystem) is a web-based, system-level intervention that has dramatically improved EID HIV-related outcomes in Kenya, Tanzania, and Malawi. The objective of this study is to implement and evaluate the impact of HITSystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in HIV care. Outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years. Primary Outcomes The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description). The proportion of HIV infected children who are virally suppressed (VL <50) at the end of the 12-month follow-up period. The proposed trial design is an unblinded CRT with two arms: the HITSystem 3.0 Intervention vs. Standard of Care (SOC) as the control. The CRT will be implemented in 20 health facilities (10 intervention and 10 control) in Western Nyanza province in Kenya and will collect data from HIV-infected children aged ≤16 years. Outcomes will focus on ART retention, adherence and viral suppression. Outcomes will be assessed among all HIV positive children aged ≤16 years attending the trial facilities for HIV care at the start of the trial, or who are diagnosed as HIV positive during the first 12 months of the trial. Follow-up data will be collected on each child for 12 months. Therefore, the total duration of the trial will be for 24 months. All HIV-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the HITSystem 3.0. The study will be conducted in Western Nyanza province, Kenya, which comprises six counties.

HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order to reduce long-term toxicity and enhance treatment adherence. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with noticeable advantages, including a high genetic barrier to drug resistance, once-daily dosing and lower risk of drug-drug interactions because this agent does not inhibit or induce cytochrome P450 isoenzymes or P-glycoprotein transporters. Dolutegravir is generally well tolerated and the INSTI class is considered to be more "metabolically friendly" compared with other drug classes such as protease inhibitors (PIs). Thus, the combination of dolutegravir plus a second active agent is a particularly inviting option for maintenance treatment and research in this area is evolving. However, though safety and efficacy of dolutegravir are well known, there is no study evaluating patient-reported outcomes (PROs), i.e. subjective and self-reported measures of the patient's health perception. In an era of the efficacy of HIV regimens are more and more comparable, the main discriminant criteria to choose the best treatment option are now adherence and self-reported measures of a patient's health - termed "patient-reported outcomes" (PROs). The study, based on a mixed methodology, include a qualitative part and a quantitative part. The qualitative study will explore patients' and health care professionals' perceptions, knowledge, and representations of triple or quadruple and dual therapies and detect the degree of agreement or disagreement between patients' and practitioners' perspectives. The quantitative study's main objective is to measure the Dovato regimen's impact on a patient's perception (Patient-Reported Outcomes - PRO) on acceptability, toxicity, preference, and Health-Related Quality of Life (HRQL). PRO are collected through self-administered questionnaires at D0 (when the patient switch treatment), M1 and M6.

HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people in order to prevent them from becoming HIV positive if exposed to HIV. Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe for use as HIV PrEP. We know from previous studies worldwide that this combination drug is very good at reducing the risk of HIV infection and several countries have implemented PrEP programmes to provide PrEP to individuals at high risk of HIV. However, it is difficult to effectively plan for a national PrEP programme in England without knowing how many people will need PrEP, how many will want to take PrEP, and how long they will stay on PrEP. In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000 people over three years. HIV negative men and women attending sexual health clinics in England will have their risk of HIV assessed by their care team and be offered PrEP if they meet the eligibility criteria. Through the trial we will be able to measure how many attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take up the offer of PrEP and how long they remain on PrEP for. There will not be any additional tests other than those recommended for the safe delivery of PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine and blood tests to monitor kidney function. Information about attendances and test results will be anonymously collected through the existing data reporting system that sexual health clinics currently use to report to Public Health England.

Human immunodeficiency virus infection is a global pandemic problem. About 35.3 million infected people in the world, so causing a great social, economical, political and cultural problems worldwide. In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases cases are increasing.According to United Nations 2016 statistics, there are about 11,000 infected people living with Human immunodeficiency virus in Egypt.

Interleukin33 organize local immune reactions, especially at epithelial barriers. ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. Amphireguline also helps immunosuppressives functions. Targetting amphiregulin for people living with HIV who has poor restauration of LTCD4+ could be a future therapy.

The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia. Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.

While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells. These infected naïve T cells may then act a viral reservoir even in patients with undetectable viral loads. Understanding when and how these cells are infected is important because it could help us to understand why patients fail therapy even if they have a persistently undetectable viral load.