View clinical trials related to HIV-1 Infection.
Filter by:In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization. Indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. From the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. In particular, previous selection of M184V may have an impact on virological response to 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG in patients with past M184V mutation in a large set of patients followed in clinical setting. Thus, the investigators propose a retrospective study of patients with HIV-RNA ≤50 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
Use of crystal methamphetamine (MA) leads to changes in sexual risk behavior, adherence to HIV prevention tools, immune response to infection, and tissue inflammation that collectively increase risk for HIV transmission among MA-using men who have sex with men (MSM), their sexual partners, and their networks. Contingency Management (CM) offers a behavioral modification tool helpful for reducing frequency of MA use, but the effects of CM on the behavioral and biological factors that promote HIV transmission in MSM networks have only been partially evaluated. The intersection of substance use, sexual risk behavior, and HIV transmission in MSM networks presents a critical problem for contemporary HIV prevention as HIV-uninfected MSM who use MA have a 16%-33% greater risk for HIV infection, while only approximately 50% of HIV-infected MA-using MSM achieve and maintain an undetectable viral load. The investigators propose to compare two different CM models to integrate substance use treatment with HIV prevention among MA-using MSM: 1) Traditional CM targeted to MA abstinence and 2) Allternative CM based on ARV adherence.
The objective of this grant is to create and test a mobile app to support ART adherence among HIV+ African American adults.
The HIV epidemic in Peru remains concentrated in the subpopulation of men who have sex with men (MSM), where the prevalence of disease has been estimated between 10-22% in recent epidemiologic surveys. Partner-based methods to limit the spread of HIV and STI co-infection, including partner notification and partner treatment, provide an important new strategy for HIV control in the region. Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been fully evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines. As a theoretical model, EPT integrates behavioral, social, and biomedical approaches to HIV/STI control in a comprehensive prevention intervention. Our proposed exploration of the social and behavioral dimensions of partner notification and treatment will provide a methodological structure for understanding the influence of EPT on behavioral decision-making processes, interpersonal factors that influence partner notification, and network patterns of STI transmission within MSM populations in Peru. The proposed study includes a screening protocol to identify eligible MSM subjects for participation in our planned study of the effect of EPT on partner notification, treatment, and linkage to HIV prevention and care services. Potential participants will complete a behavioral survey and undergo physical examination and testing for HIV, syphilis, gonorrhea, and chlamydia. Participants diagnosed with Gonorrhea and/or Chlamydia (at any anatomic site) will be eligible for enrollment in our Partner Management study of EPT and the HIV prevention cascade among MSM in Peru. Participants in the Partner Management study will be randomly assigned to receive either standard of care partner notification counseling or standard counseling along with a maximum of five antibiotic treatment packets to deliver to their recent sexual partners. Participants will be asked to return to the site after 21 days to report on their actual partner notification behavior, with differences in notification evaluated between the two groups. Participants will then work with a study counselor to identify their recent partners and, if the participant agrees, to provide contact information so that the study team can contact these partners. Study staff will either confirm that the partner has already been notified, or provide notification of their likely STI exposure. After informing partners of their STI exposure, staff will ask partners to provide verbal consent to a single question evaluation (whether or not the partner had previously been informed of their exposure) to verify participant-reported behavior. Partners will also be asked to visit the study site to complete a brief survey of their sexual practices and treatment-seeking behavior, as well as to undergo testing for HIV and STIs. All of the above data will be used to construct models of the spread of HIV and STIs in local MSM networks, and the potential effect of EPT on controlling the spread of STIs in this population.
The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
HIV-CORE 006 is a Phase 1 double-blind placebo-controlled trial, in which the mosaic immunogens are delivered by a prime-boost regimen of non-replicating simian adenovirus followed by non-replicating poxvirus MVA. Volunteers will be randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously. The trial will recruit healthy African adults 18-50 years of age, who are HIV-uninfected and at low risk of HIV infection. The trial is designed to enrol 88 healthy men and women, who will be randomised to receive either the vaccine regimen or placebo in a ratio of 72:16: - Vaccine Arm (ChAdOx1.tHIVconsv1 prime followed by MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at 4 weeks after enrolment); 72 vaccine recipients; - Placebo Arm; 16 recipients To maintain blinding, all volunteers will receive two injections with half dose into the deltoid region of each arm of ChAdOx1.tHIVconsv1 or placebo at enrolment, and two injections (MVA.tHIVconsv3 or placebo into one deltoid region and MVA.tHIVconsv4 or placebo into the other) at 4 weeks after enrolment. The primary goal of assessing safety and immunogenicity will be served by weighting the randomisation toward vaccinees.
The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes Hypothesis: Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infection could have different cytokine profile and cellular immune response after SARS-CoV-2 infection, leading to a differential outcome,