Active clinical trials for "HIV Infections"

The purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in Kenya.

Low viral replication persistence and immune activation remain important therapeutic challenge in the new HAART era. They are associated with more rapid disease progression, increased risk of mortality and non-AIDS defining events. Soluble biomarkers are a convenient way of assessing immune activation and inflammation in HIV-infected patients receiving effective treatment. There are limited data describing the different effects of currently recommended antiretroviral regimens on immune activation and inflammation during HIV infection. Several studies have shown that raltegravir (the first approved drug from integrase inhibitor class) seems to have more impact on decreasing systemic inflammation compared with other drug classes. Integrase inhibitors may decrease inflammation and immune activation more than other antiretroviral drugs, because they are more lipid friendly and may concentrate better in enterocytes. The aim of this observational study is to compare the impact of different integrase inhibitor based regimen on changes in markers of inflammation (Il-2, IL-6, sTNFR-1, sCD14, sCD163, sICAM, hsRCP , sVCAM, LPS, D-dimer) during the first year of effective first-line combination. This is a 48-week observational retrospective study, to compare the change in infiammatory markers between naïve patients who start INI based regimen. Participants will be recruited from the HIV outpatient clinic. The study compare the impact of commonly used first-line antiretroviral drugs on soluble markers of inflammation and immune activation. The study is conducted on treatment-naive HIV-infected patients who experience a rapid and persistent virological response and that do not switch their initial regimen for at least 1 years. The analyses will be adjusted for baseline characteristics that might influence the choice of cART regimen or affect biomarker levels, such as age, smoking status, CD4 cell count, plasma HIV-1 viral load. Investigators enroll patients with a rapid and persistent virological response and that do not experience any blips. Cryopreserved plasma sample are obtained at baseline and at month 6 and 12 after treatment starting. Two NRTI backbone combinations (TDF/FTC vs ABC/3TC) and three third agents (RAL vs ELV vs DTG) will be compared in a factorial design. The results will be expressed as the estimated percentage difference between the mean fold changes observed with a given drug, using TDF/FTC and RAL as the reference groups for the comparison.

The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.

Next generation real-time monitoring for PrEP adherence in young Kenyan women

The primary objective of this proposed one-year (January 01, 2017 to December 31,2017) project is to assess whether a mindfulness based intervention('Mindful Living With Stress') will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress. Based on the efficacy of previous studies in stress reduction, it is hypothesized that 'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction program in China.

A randomised phase I trial of a monoclonal antibody which neutralises HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to assess the safety and reactogenicity

This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.

HIV testing is essential in shortening the time to identify a new infection, the first 90 of the UNAIDS 90-90-90 targets. However, over one-third of the men who have sex with men (MSM) had never been tested for HIV; even if they did, one-fifth had their tests done more than a year ago. Assortative mixing pattern observed in the HIV-positive MSM group shaped the transmission dynamics and could be leveraged for intervention. Barriers to access HIV testing services could, on the other hand, be hurdled by self-tests. A network approach for intervention could therefore be promising in delivering effective HIV self-tests. To experiment with such an approach, a 2-phase study was conceptualised incorporating actual network-based referred HIV self-tests and an agent-based simulation evaluating its impact. Sixty-four MSM would be recruited as seeds for promoting HIV self-tests within their network and those being referred could refer their friends for the same after passing online training. To facilitate the process, an online platform would be developed offering information, collecting informed consent, requesting HIV self-test kits, returning results, performing online training, and referring peers. Participants could opt to receive self-tests by delivery or to conduct it on-site with staff assistance. A hotline with video conferencing support would be maintained to assist those who self-test at home. They could also choose between blood and oral fluid tests. Two user interfaces, namely gamification and neumorphism, would be randomly assigned. Primary outcomes to measure are number and proportion of MSM who had never or not tested within 12 months and the associating factors, and usability of the two user interfaces. Data collected in the empirical study would be used for parameterising the agent-based simulation to evaluate the impact of the approach in increasing testing coverage and shortening time to diagnosis. Its economic assessment would also be performed to cost each new infection to be identified. The approach could be feasible and effective to be adopted for future broader implementation for peer-led HIV self-test kit or HIV prevention message distribution.

Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in France. Part of these HIV infections occurred after arrival in France, in relation to social hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties. Many actors strive for an easier access to healthcare services for immigrants; however the mere supply of knowledge and medicalised solutions is not enough to make persons adopt prevention behaviours. It seems necessary to act upon empowerment to bring resources to individuals and communities in order to improve their autonomy and action capacity. Civil Society Organisations and researchers join forces in the MAKASI interventional research which aims at reinforcing immigrants' empowerment in sexual health in order to reduce their exposure to sexual risks. Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the principles of motivational interviewing, using an Active Referral system to social or sanitary services relevant to the person's needs. Our hypothesis is that this intervention is going to reinforce four dimensions of empowerment in sexual health among immigrants: the capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on these four dimensions, and at evaluating its processes and efficiency (cost-efficacy). Methods: The intervention is delivered within the mobile units of Afrique Avenir in the public spaces where African and Caribbean populations live and work. The evaluation uses integrated mixed-method approach, combining a quantitative evaluation of impact and a qualitative research on processes. The measure of impact will be done by comparing indicators on the four dimensions of empowerment in sexual health and indicators of exposure to sexual risks, between an arm where the intervention is immediate and an arm where the intervention is differed by 3 months (control arm). The qualitative evaluation of the intervention processes will be based upon an ethnographic approach of the intervention and the participants' experience. Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in sexual health.