View clinical trials related to HIV Infection.
Filter by:Testing and Linkage to Care for Injecting Drug Users in Kenya: Interventions for people who inject drugs (PWID) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they contribute a growing proportion of incident HIV infections. This study will leverage a historic decision in Kenya to launch needle exchange program (NSP) and related services for this most-at-risk population (MARP). The investigators will use this NSP/MARP platform to seek out PWID, deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers, and evaluate community viral load impact using a stepped wedge cluster-randomized design. Lessons learned will have important applicability throughout sub-Saharan African. HCV Among PWID in Kenya: A Supplement to the TLC-IDU study: The prevalence of HCV in Kenya, where an increasing number of people who inject drugs (PWID) live and are becoming HIV- as well as HCV-infected, has not been defined. We will establish HCV prevalence among PWID in Nairobi, Western, and Coastal region by adding HCV rapid and confirmatory tests in our parent PWID study (TLC-IDU Kenya); deliver appropriate counseling and treatment options to those eligible; collect HCV treatment adherence data; and disseminate study findings. These data will provide novel and relevant information about HCV and HIV co-infection in Kenya among PWID that will be immediately applicable in terms of public health impact to national and regional HCV testing, counseling, and clinical management policy.
Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL) cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in HIV-infected individuals, and has been associated with HIV infection itself and antiretroviral therapy (ART). These abnormalities are well-established markers of cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk of CVD associated with ART exposure over and above that conveyed by traditional cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual clinical strategy remains to add a statin treatment. Recent studies suggested ART switch can represent an interesting alternative to statins to reduce lipid plasma levels. The purpose of this study is to evaluate the frequency with which the replacement of LPV/r (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate the necessity to administer statins. A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed. At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined. Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will be measured at baseline, at drug switch and at the end of the study Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for study drug will be done at week-4 and week-12, Returned study medication will be counted and the amount notified on the Case Report Form (CRF).
As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP). Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe. Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up. A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.
Highly active antiretroviral therapy (HAART), the current standard of care for treatment of HIV infection, is highly effective when taken appropriately. Before starting this treatment, a person must be aware of their HIV status and present to a clinic for medical care. They then undergo screening procedures (medical assessment and laboratory tests) to determine whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe for them. In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV infection among users of illicit drugs. However, HIV-infected drug users often do not present to the medical system and complete the process necessary to start HAART. Given the known benefits of HAART, new strategies are required to increase rates of HAART initiation in this group. Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not been established as a means to improve HAART uptake. The proposed research primarily seeks to assess the effectiveness of monetary-based CM in engaging HIV-infected drug users in HAART programs. Drug users identified through outreach will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be offered a monetary-based reinforcer to participate (n=150) and participants in the second arm will be offered no reinforcer (n=150). Participation involves reporting to the study site for formal study of eligibility screening, consisting of clinical evaluation, medical history and laboratory testing required to determine eligibility to receive HAART. Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures. Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly more likely to complete HAART eligibility screening than those not offered a reinforcer.
This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level. The proposed strategy is a two steps process: - Extensive HIV counselling and testing, and comprehensive prevention programme among a target population - Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria. The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in men who have sex with men who may be at risk of getting HIV infection through sex and women who may be at risk of getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC), MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. The MVC-containing arms will be compared to TDF/FTC alone and in combination.
The proposed study is a substudy of ATN 106 and a cross sectional study intended to be conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a review of the subjects' medical chart and a collection of an oral rinse sample.
The proposed study seeks to continue Connect to Protect® (C2P) community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at nine sites.
In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV infection among users of illicit drugs. Among drug users who present to care and start highly active antiretroviral therapy (HAART), retention in care and adherence to their treatment regimen may be less than optimal. Given the known benefits of HAART on both the individual and populational levels, new strategies are required to help retain HIV-infected drug users on HAART. Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not been established as a means to improve retention in HAART programs. The proposed research primarily seeks to assess the effectiveness of monetary-based CM in retaining HIV-infected drug users in HAART programs. 240 HAART-eligible subjects will be randomized in a 2:1 ratio to either receive (n=160) the reinforcer or to a control arm (n=80). All subjects will receive HAART and standard care, and those randomized to the reinforcer arm will receive escalating reinforcement initially for attendance at each clinic visit (until month 6 after starting HAART) and subsequently (until month 12 after starting HAART) will receive an escalating variable reinforcer for each month in which a plasma viral load less than or equal to 100 copies/mL is maintained. Our hypotheses are that drug users initiating HAART and randomly selected to receive a reinforcer for attending clinic visits then maintaining monthly virologic suppression during the first 52 weeks after HAART initiation will be significantly more likely to achieve virologic suppression at 52 weeks, will have a significantly longer duration of sustained virologic suppression during the first 52 weeks, and will be significantly more likely to maintain virologic suppression at 72 weeks after HAART initiation, than those not offered a reinforcer.
The study is being conducted as the most common side effect of the HIV drug atazanavir (taken with ritonavir) is hyperbilirubinaemia. Bilirubin is a normal waste product from the body and gets broken down in the liver so it can leave the body through the gut. Atazanavir slows the breakdown of this chemical, which can cause jaundice (yellowing of the skin) and/or scleral icterus (yellowing of the eyes). This is completely harmless; in fact up to 1 in 10 of the UK population have an inherited condition that causes the same yellowing. However, some patients don't like this side effect and it is the commonest reason for switching off the drug. A study in people with Gilberts syndrome (the inherited condition that causes the same changes in the chemical bilirubin) showed that a mineral supplement (zinc sulphate) reduced the levels of bilirubin in the blood. The aim of this study is to see if using zinc supplements can achieve the same effect in patients with high bilirubin due to atazanavir use.