View clinical trials related to HIV Infections.
Filter by:Background Chronic HIV infection leads to a dysregulated immune system, even when full viral suppression is achieved. HIV causes persistent immune activation, relating to an array of common non-AIDS-related diseases such as cardiovascular disease (CVD) and non-alcoholic fatty liver disease (NAFLD). On the other hand, accelerated ageing of the immune system hinders effective immunity against infectious diseases and cancer. Likewise, this derailed inflammatory balance creates a niche for persistent viral replication and reservoir, and prevents cure or functional cure. Mechanisms behind this phenomenon are poorly understood. Inclusion of a larger cohort of HIV-infected patients allows for a more precise assessment of the factors underlying the immune dysregulation. Primary Objectives - Identify a set of candidate biomarkers that correlate with particular non-AIDS-related comorbidities - Unravel biological processes associated with extreme HIV clinical phenotypes. - Find therapeutic targets to identify novel assets or for repurposing of clinical phase assets from other disease areas for HIV. Secondary Objectives - Evaluate potential relationship of host/immune profiles on efficacy, safety, and tolerability of standard care regimens. - Evaluate the contribution of age, sex, and genetics in host-immune profiles that are: - distinct to HIV infection relative to controls in other cohorts; - associated with non-AIDS-related comorbidities in HIV infection relative to non-HIV chronic disease. Study design 2000 HIV patients will be included in the cohort. The investigators estimate a 2-year inclusion and 2-year follow-up period and will strive for the inclusion of several clinical phenotypes and classical risk group patients. Patients will be recruited from four Dutch HIV treatment centers. At inclusion 1. Collection of metadata using questionnaires and patient medical records 2. Asses co-pathology (CVD and NAFLD) 3. Blood will be drawn for genetic, epigenetic, proteomic, metabolomic, microbiome, immunological, and virological analyses After 2 years follow-up 1. Collection of metadata using questionnaires and patient medical records 2. Asses co-pathology (CVD and NAFLD) 3. Blood samples will be collected for biomarker and infection/inflammation parameter analysis
HIV patients are likely to suffer from opportunistic infections, in absence of highly active retroviral therapy. This happens due to lack of awareness of HIV status among patients or unresponsive to anti retroviral drugs. This study is for the prevalence of AIDS defining OIs among treatment naive HIV patients.
This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will be a pilot randomized trial, comparing culturally-tailored CBSM to standard CBSM for dually-diagnosed participants. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups. Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.
The strategy to support virological suppression on second-line antiretroviral treatment (ART) includes the provision of ART that has a low pill burden, good tolerability, low toxicity, is easily monitored, has a high barrier to resistance, and that is low cost. The fixed-dose combination of tenofovir-lamivudine-dolutegravir offers significant advantage as a potential second-line regimen compared to the World Health Organization standard of care second-line regimen of zidovudine-lamivudine-dolutegravir, in terms of cost, tolerability and monitoring requirements. The ARTIST study is a phase 2, randomised, double-blind, placebo-controlled trial aiming to determine the proportion of patients achieving virological suppression when recycling the tenofovir-emtricitabine/lamivudine backbone with dolutegravir (tenofovir-lamivudine-dolutegravir fixed-dose combination) as a second-line with and without a lead-in supplementary dose of dolutegravir, in patients failing a tenofovir-emtricitabine/lamivudine-efavirenz first-line regimen. There is evidence to suggest that even in the presence of resistance mutations to tenofovir and lamivudine (K65R or M184V/I), using this backbone with dolutegravir will provide an effective second-line regimen in patients who have failed a first-line regimen of tenofovir-emtricitabine/lamivudine-efavirenz. The strategy of giving a lead-in supplementary dose of dolutegravir is in view of the inducing effect of efavirenz on dolutegravir metabolism and transport that persists for 2 weeks after efavirenz is stopped; the inducing effect decreases with time after efavirenz is stopped. Given that these patients will have elevated viral loads, a high baseline risk of nucleoside reverse transcriptase inhibitor (NRTI) resistance and efavirenz resistance, and the inducing effect of efavirenz on dolutegravir metabolism and transport that persists for 2 weeks, this study will comprise two stages. The first stage will evaluate virological suppression in 62 participants initiated on the fixed-dose combination of tenofovir-lamivudine-dolutegravir with a lead-in supplementary dose of dolutegravir for the first 14 days. The study will progress to the second stage if this strategy proves effective, and 130 participants will then be randomised to receive the fixed-dose combination of tenofovir-lamivudine-dolutegravir with and without this lead-in dose. The primary endpoint is virological suppression (viral load <50 copies/mL) at 24 weeks. A pharmacokinetic sub-study will be conducted on 12 participants in stage 1 and 24 participants in stage 2, to assess the trough concentrations of dolutegravir and off-treatment concentrations of efavirenz at day 3, 7, 14, and 28. This is to evaluate the need for the lead-in supplementary dose of dolutegravir.
This trial evaluates options for second-line antiretroviral therapy in patients failing on a non-nucleoside reverse transcriptase inhibitor (NNRTI) and tenofovir (TDF)-based first-line regimen in the setting of the public health approach in sub-Saharan Africa (with assumed substantial nucleoside reverse transcriptase inhibitor (NRTI) cross-resistance). The trial tests two hypotheses. Firstly that a regimen of dolutegravir (DTG) with two NRTIs is non-inferior to a regimen of ritonavir-boosted darunavir (DRV/r) with two NRTIs. Secondly that continuing an NRTI regimen of TDF and lamivudine (3TC) is non-inferior to switching to zidovudine (ZDV) and 3TC. The trial is a parallel group, open-label, multi-centre, factorial (2X2) randomised, controlled trial. Patients will be randomised to either DTG or DRV/r with a second randomisation to ZDV and 3TC or TDF and 3TC. Treatment efficacy will be monitored by testing viral load (VL). Analyses will compare DRV/r with DTG; and ZDV/3TC with TDF/3TC by intention to treat analysis on the primary outcome parameter of plasma VL below 400 copies/ml at 48 weeks. Trial follow-up will continue to 96 weeks.
To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
The human immunodeficiency virus (HIV) remains at the moment a major public health problem. The figures currently report 37 million people infected with HIV worldwide, as well as 2 million new infections every year, the majority of which are men who have sex with men (MSM). HIV research has accounted for more than 335,000 publications on PubMed since its first description in 1981. However, many questions remain unanswered, especially regarding the risk factors and protective factors, its transmission and acquisition, during sexual intercourse. By creating a background on PubMed with the keyword "HIV", we can see that at the end of the 80's, it was already established that male circumcision decreased the risk of transmission of HIV by 50 to 60%. Multiple hypotheses have been studied to justify this discovery, such as the reduction of micro-traumatisms, the modification of keratinization, the modification of penile anatomy induced by foreskin removal. In parallel, the rise of the study of the human microbiota, which refers to all microorganisms (bacteria, viruses, archaea, fungi and parasites) living in a specific environment, the human body, and this in a healthy or pathological situation. There is evidence that the microbiota may be involved in the pathogenesis of various diseases and may play a major role in the homeostasis of the human body. This implication has also interested researchers in the field of HIV : the protective role of circumcision in the acquisition and transmission of HIV has therefore begun to be studied in terms of the modification of the penile microbiome. The first studies showed that circumcision had an impact on the abundance of bacteria present in the penis in humans, and modified the aerobic / anaerobic ratio in favor of the increase of aerobic bacteria. The first hypothesis was that circumcision played a protective role in the acquisition and transmission of HIV through a decrease in the diversity of the penile microbiota and in particular anaerobes. This discovery was disrupted by the emergence of studies tending to question a microbiota predisposing to the risk of HIV acquisition in both men and women. Indeed, it has been shown that certain bacteria (Prevotella, Dialister, ...) could favor the acquisition of the virus by the attraction in their wake of inflammation cells such as CD4 and Langerhans cells which would facilitate by their presence. , the penetration of the virus. This hypothesis has been proven in studies of bacterial vaginosis, which is known to be a risk factor for HIV acquisition and transmission. In 2012, results showed that the loss of Lactobacillus, in favor of anaerobic increases such as Gardnerella, Atopobium, and Prevotella, increased this risk against the HIV virus. Similarly, 7 bacteria have recently been incriminated in this phenomenon of susceptibility to HIV acquisition (Parvimonas, Gemella asaccharolytica, Mycoplasma hominis, Leptotrichia / Sneathia, Eggerthellaspecies and Megasphaeraspecies).Being committed to the exploration of the human microbiota in particular by culture, we propose to extend the knowledge of balano-preputial furrow 's microbiota in patients infected by HIV or not and supported in department Infectious Diseases. It is in this context, that a preliminary study carried out at the IHU between January and July 2018 made it possible to describe the existence of variability of the microbiota according to various criteria such as circumcision, HIV infection and sexual practices.
The PRINCESSE study will implement a comprehensive package of services in sexual and reproductive health for female sex workers in the region of San Pedro in Cote d'Ivoire, including screening, prevention and treatment for HIV, viral hepatitis B, sexually transmitted infections and family planning. All services will be available in mobiles clinics operating on prostitution sites and organized for a chronic follow-up of participants.