View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
Although effective treatments are currently available to treat human immunodeficiency virus (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy (HAART) regimens is well documented in individuals with HIV. This is especially true for adolescents and young adults (AYA), where rates of adherence range from 20 to 100%. Nonadherence has significant implications for subsequent treatment response and health outcomes, including poor virologic response, development of drug resistance, and mortality. Of note, previous research has suggested that every 1% increase in nonadherence is related to a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus transmission. Thus, nonadherence to HAART is a significant public health issue. The objective of the proposed research plan is to systematically examine an individualized, behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current intervention will support AYA participation in brief, staff-delivered instruction in adherence-promotion skills. Individualized behavioral analysis and motivational interviewing will be applied to provide effective solutions for current barriers to HAART adherence before and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for Adults and Adolescents.
The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention. They study hypothesis are the following: 1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group; 2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group; 3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.
The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).
This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared with continuing the subject's current suppressive regimen through 24 weeks. The study will be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI). Eligible subjects will be randomly assigned 1:1 to continue their current regimen (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects) once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r).
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug interaction between DTG and DCV is expected to be low and this study is to be performed as confirmation. This will be a single-center, open-label, three-period, crossover study in healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h
DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744 (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed by a one week washout period. Following safety lab assessments from the Oral Phase, participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744 LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg of 744 or a matching control