Active clinical trials for "HIV Infections"

The aim of this cross-over study is to compare the relative bioavailability and pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state. Subjects will have a follow-up visit 7-10 days post last dose of study treatment. Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy subjects will participate in Part 2 of the study. The total duration of Part 1 will be approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks. TIVICAY® is a trademark of the GlaxoSmithKline group of companies.

This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1 and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and PK parameters of the tablet formulation when administered under fasting and fed conditions.

The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).

This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

The purpose of this two arm randomized clinical trial (RCT) is to test if a smoking cessation program called Quit for Life (QFL) which was developed by the investigators is effective for patients in China with HIV who smoke. This program is designed to suit the needs of people with HIV who smoke in China. Eligible participants who provide consent will be randomized into either the QFL or the Control group. The QFL group will receive a quit smoking program that lasts for 8 weeks with two parts- 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit. Messages sent to the participants' cell phone using WeChat. The Control group will not have sessions with a trained counselor or receive messages sent to their cell phone. Both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.

This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM) injection respectively, to separate vastus lateralis muscles on each leg. Cabotegravir is an integrase inhibitor being developed in combination with rilpivirine, a non-nucleoside reverse transcriptase inhibitor, for the treatment of human immunodeficiency virus (HIV). The objective is to evaluate pharmacokinetics, tolerability, and safety of cabotegravir long acting plus rilpivirine long acting administered concomitantly as two separate IM injections in the vastus lateralis muscle of adult healthy participants. The screening phase will be of 30 days, oral lead-in (OLI) phase of 28 days, there will be washout period of 10-14 days, followed by an injection phase and follow-up period will be up to 52-weeks. Approximately 15 adult healthy participants will be enrolled.

The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.

This is a single-site, longitudinal, open-label, interventional study for evaluating the effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.

Physical activity delays all-cause mortality in the general population and reduces the risk of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et al., 2011). These diseases are associated with chronic inflammation, which is characterized by activation of inflammatory signalling pathways with abnormal production of cytokines and other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have consistently shown an association between physical inactivity and low-grade systemic inflammation and interventional studies a reduction of inflammatory markers following exercise (Beavers et al., 2010). Chronic inflammation is also a predominant feature of treated human immunodeficiency virus (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al., 2011), and several studies have shown an association between chronic inflammation and higher cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012). Recently, the investigators performed a pilot study of moderate physical activity that enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12 weeks of training cholesterol profile and soluble and cell inflammatory markers improved significantly. However, because of the considerable individual variability in exercise responses, a program of physical activity needs be adjusted on an individual basis to be most effective. During recent years, the use of mobile technologies has been implemented for health monitoring interventions, including exercise. We hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. The investigators hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. Therefore, the aim of this project is to improve health and quality of life of patients living with HIV through self-empowerment by use of an innovative mobile application, in order to assist and monitor individualized program of physical activity and diet recommendation. OBJECTIVES Primary To compare the improvement of physical fitness between the EG and CG groups after 16 weeks of training. Secondary To compare the improvement of the following characteristics between the EG and CG groups after 16 weeks of training: anthropometry, Blood lipids, Inflammatory markers, Quality of Life, 4. Mood State. ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of training. Secondary The secondary endpoints will be assessed by the 16-week changes in the following measures: BMI and %Fat Mass, Blood Total-, LDL-, HDL-Cholesterol, Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers, F12 questionnaire, Profile of Mood State questionnaire.