View clinical trials related to HIV-1 Infection.
Filter by:D²EFT-GIC is a substudy of D²EFT study (NCT03017872), a randomised clinical trial of second-line antiretroviral therapies. The goal of D²EFT-GIC is to evaluate a novel tool, the "Graphical Informed Consent" (GIC), within D²EFT. The GIC is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations, with an explanatory script for researchers, that complements the mandatory written participant information sheet and consent form. The investigators propose to assess the acceptability and feasibility of this tool from the participants and researchers perspectives. The GIC will be first pre-tested in one or more site(s) - where the informed consent process is challenging because of literacy, language or culture barriers - in 10 prospective participants for D²EFT. If this stage shows there is no negative impact of the GIC on the consent process, the second stage will study the feasibility of implementing the GIC in the usual practice.
Social distancing measures put in place to combat the COVID-19 disease pandemic may increase social isolation and impact cardiovascular disease prevention behaviors among people living with HIV (PLWH). This study builds on a previously developed nurse-led intervention to improve blood pressure and cholesterol care for PLWH. The investigators will adapt the intervention to be administered virtually in order to facilitate cardiovascular prevention care within the US health care system which has sustained long-term changes as a result of the COVID-19 pandemic. The implementation and effectiveness of the intervention will be tested in a 12-month single arm intervention study.
Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term antiretroviral therapy (ART). Two-drug regimens (2DRs) have been investigated as a means for reducing the number of antiretroviral agents (ARVs) taken by individuals who need lifelong ART. Dovato® (Dolutegravir/lamivudine) has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US Food and Drug Administration (FDA) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato ® as an initial treatment in HIV-naÏve patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients. Our results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with dolutegravir (DTG) + lamivudine (3TC), to verify efficacy and tolerance in real life. Our hypothesis is that the data will be similar to those reported in clinical trials.
According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.
This is a phase I, open-label, dose-escalation study to investigate short-term safety, pharmacokinetics, and antiviral activity of UB-421 SC with 4 weekly doses in treatment naive HIV-1 infected patients. Eligible (n=6 per dose cohort) subjects will be sequentially enrolled into 3 escalating-dose cohorts to receive 4 weekly fixed doses of UB-421 SC at either 250 mg (Cohort A), 500 mg (Cohort B) or 700 mg (Cohort C). Subjects should be followed for safety for additional 4 weeks after the last UB-421 SC dosing. In order to control viral load while minimizing confounding in safety assessment, subjects can initiate standard anti-retroviral therapy (ART) two weeks after the last UB-421 SC dosing. Escalation to the next higher dose cohort will be determined based on dose limited toxicity (DLT) evaluation. The dose escalation will be stopped if ≥ 2/6 subjects experience DLT or when clinical trial steering committee (CTSC) determines it is not suitable to escalate the dose level. In this study, DLT is defined as any ≥ grade 3 AE occurred within 21 days from prior UB-421 SC dosing and is considered drug related. When there is any ≥grade 3 AE(s) occurred within 21 days from prior UB-421 SC dosing in any subject out of the current dose cohort (n=6), the duty of the CTSC will be initiated. The CTSC will be responsible for DLT evaluation. The committee members will evaluate the safety data of all subjects in each cohort through baseline to at least 21 days following the last UB-421 SC dosing. The administration of the next higher dose level at TV1 will be conducted after the committee grants the dose escalation. However, dose escalation will be proceeded if there is no ≥ grade 3 AE and upon agreement from all investigators without holding the steering committee meeting. Subjects will be assessed at Screening, weekly during Treatment Period and Follow-up Period. The assessment includes physical examination, vital sign, laboratory parameters, HIV-1 viral load, CD4+ and CD8+ T-cell counts. Samples for the drug concentration measurement will be collected at weekly intervals throughout the study, immediately before UB-421 SC dosing. Additional intensive PK sampling will be scheduled during the first dosing interval (from TV1 to TV2) at 1, 3, 6, 24, 48, 72 and 96 hours post first UB-421 SC dosing for PK subgroup (at least 3 subjects per dose cohort). The immunogenicity of UB-421 SC will be monitored by measuring anti-UB-421 antibodies in pre-dose serum samples at day 0 and post-dose serum at day 14, 28, 35, 42 and 49. Viral reservoir, immunophenotyping and CD4+ (D1) receptor occupancy will also be explored. Subjects should discontinue from UB-421 SC treatment if they experience a sustained decrease from baseline in CD4+ (D2) T cell counts of ≧50% at two consecutive visits or drug-related AE(s) with severity grade 3 or 4 (according to the Division of AIDS, National Institute of Allergy and Infectious Diseases (DAIDS) AE grading).
UB-421 subcutaneous formulation (UB-421 SC) is developed to provide HIV infected patients a more convenient drug delivery method. UB-421 SC injection, with significantly less injection time than IV infusions and with opportunity of self-administration or administered in general medical setting (in addition to HIV-specific clinic), can provide patient a more convenient option. This UB-421 SC phase I study will be conducted to investigate short-term safety, pharmacokinetics and anti-viral activity of UB-421 SC at three dose levels in ART-treated aviremic subjects and treatment naive HIV-infected subjects. The current UB-421 SC formulation (125 mg/ml) is at least 10-fold more concentrated than UB-421 IV (10 mg/ml). The highly concentrated formulation makes weekly UB-421 subcutaneous injections feasible. This study will form the basis of UB-421 SC in combination with antiretroviral agents (ARV) for treating HIV infected viremic patients in the future clinical trials.
A cross-sectional study that uses ecological data from (1) PLWHIV under care at 31st December 2017, and (2) from yearly admissions to care occurred during 2013 - 2017, from centers belonging to LAW-HIV.
Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.
ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon. The main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in Cameroon
The present study is designed to determine the effect of islatravir (ISL) [MK-8591] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve from dosing to 24 hours postdose (AUC0-24) of S-methadone and R-methadone in participants on oral methadone therapy. It is hypothesized that the plasma AUC0-24hr for S- and R-methadone will be similar after methadone alone compared to methadone and ISL 60 mg coadministration.