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Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV). Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC. This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study. The study population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens for any reason.
Human immunodeficiency virus (HIV) infection is a public health problem with enormous personal, and social losses. According to the National Mexican HIV/AIDS survey, more than 235,000 new cases of HIV infection were reported in Mexico between 1983 and 2015. HIV infection is characterized by persistent immune activation and constant turnover of T cells. This leads to a precipitous fall in the number of CD4 + and CD8 + T cells, as well as to an early immunosenescence phenomenon that conditions susceptibility to opportunistic infections and a profound decrease in circulating and mucosal T cells. In these patients, modulation of the immune response represents a promising mechanism to maintain immunological homeostasis and prevent the development of pathology. From this perspective, it is feasible that lesser immune activation - rather than accelerating the progression of infection - may be an important actor in controlling infection and delaying the progression from chronic infection to acquired immunodeficiency syndrome (AIDS) . The administration of highly active antiretroviral therapy (ART) has resulted in a reduction in the mortality of these patients, although the occurrence of late morbidity due to both infection and treatment has increased. Unfortunately, even in cluntries with complete coverage for HIV-infection, a large group of patients do not start treatment until late stages, in which immunosenescence is profound and the possibilities of immunological recovery (increase in T cell counts CD4 +, normalization of the CD4 + / CD8 + index, decrease in susceptibility to opportunists, normalization in the cellular response to vaccines) are very low. In this context, finding new immuno-modulatory strategies that are both easily applicable and potentially improving survival and quality of life is crucial. The therapeutic use of neuroimmune regulators in HIV infection has been poorly explored. In brief, the nervous system has evolutionary mechanisms of reflex control of the inflammatory response, such as cholinergic anti-inflammatory reflex (RCA). Cholinergic stimulation through the use of nicotinic agonists has shown promising effects in murine and cellular models of systemic inflammation. Since cholinergic agonists are rapidly degraded or cause side effects, we performed a pilot study using pyridostigmine (Mestinon®), an acetylcholinesterase inhibitor (ACh-E), in HIV-infected patients. We observed that administration of pyridostigmine decreases the activation and proliferation of HIV-infected T cells, reduces the production of interferon (IFN) -gamma and increases that of interleukin (IL) -10 (Valdés-Ferrer SI et al., AIDS Research And Human Retrovir 2009). In a second open-label pilot study in seven chronically infected patients with full virological suppression but without concomitant elevation of CD4+ T cell counts, we found that the addition of pyridostigmine to ART led to a sustained and significant increase in the number of CD4 + T cells (PRS record: NCT00518154; in preparation for publication). These results suggest that the addition of pyridostigmine to antiretroviral therapy may be beneficial in achieving and maintaining immunological homeostasis in patients with HIV. The present study will address the potential effectiveness of add-on pyridostigmine (90mg, once per day, per oris) on CD4+ T cell counts, CD4+/CD8+ ratio, as well as ex-vivo markers of T cell phenotype and activity. The study is designed as a 24-week crossover study where patients will start a 12-week of pyridostigmine or placebo, and then crossing-over for an aditional 12 weeks (placebo-to-pyridostigmine, and pyrodistigmine-to-placebo). Since pyridostigmine is a commonly used drug for both myasthenia gravis and as a preventive in biological warfare cases, if our hypotheses are correct, the results will be easily extended to clinical practice, as there is enough long-term evidence of utility and safety of the drug.
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.
The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.
The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability, feasibility and effectiveness of the targeted provider-initiated-testing and counseling (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC) among children and adolescents in Cameroon. The new knowledge generated will inform programming of more suitable strategies to identify HIV-infected children and adolescents and this will contribute to reducing the current global gap in HIV treatment among this subpopulation group.
The proposed pilot research has three aims: 1) to determine the feasibility and acceptability of provision of HIV self-testing kit in order to increase uptake and engagement of HIV testing among emergency department patients who decline conventional emergency department HIV testing and to increase the engagement of HIV testing at a regular basis for those with an increased risk for HIV (the index participants); 2) to determine the uptake and engagement of HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and acceptability of HIV self-testing kit referral among partners or peers of the index participants. The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency department on (1) patients who decline routine HIV testing offer and (2) patients who are at an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit group which the investigators will provide a free Food and Drug Administration-approved HIV self-testing home kit for the participant to take it home or to reference group which the investigators will not provide the self-testing kit. Consented patients in both groups will fill out a short survey regarding their socio-demographic information as well as their experience and perceptions regarding HIV testing. For patients who are in the HIV self-testing kit group, they will be asked if they would like to take a free HIV self-testing home kit home. Participants in this group will also receive information regarding how to access "I Want The Kit" website to report the completion of HIV self-testing at home. For patients who are in the reference group, a standard pamphlet regarding the importance of HIV testing and HIV testing venues in Baltimore City used by emergency department-based HIV testing program will be provided to the patients. Follow-up questionnaires will inquire regarding the patient's experience regarding HIV testing since their index visit. When the participants in the HIV self-testing kit group in Aim 1, they will also be provided 5 referral cards for their partners and peers for them to request a free HIV self-testing kit from the "I Want The Kit" website. At the 1-month phone follow-up, the investigators will ask participants if they are able to give the referral cards to their partner(s) or friend(s), how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from the "I Want The Kit" website.
MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy (ART) and demographically matched uninfected adults to evaluate muscle and aging.
The investigators propose to develop and pilot an HIV prevention intervention based on rectal STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. The intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic acid testing to identify the members of the MSM population at greatest short-term risk for HIV infection; 2) To provide single-dose antibiotic treatment to control the immune activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand and modify recent high-risk sexual practices that led to rectal STI acquisition and that increase future HIV risk. The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and 50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected participants will be given single-dose antibiotic therapy and randomized to receive single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in GC/CT-infected and -uninfected MSM.
This is a retrospective observational multicenter cohort study based on 271 consecutive HIV-HCV coinfected patients who underwent liver transplantation (LT) between 2002 and 2012 in 23 centers from Spain and who were prospectively followed until January 2016. The main objective of this study is to analyze the effectiveness and safety of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus Raltegravir (RAL)- based antiretroviral therapy (ART) compared to other antiretroviral regimens in liver transplant (LT) HIV-HCV co-infected recipients. In addition, the investigators want to know the rejection rates in patients taking RAL-based ART in comparison with other ART-regimens and to know the efficacy and safety of direct antiviral agents (DAAs) against HCV in HIV-infected liver transplant recipients taking RAL-based ART.
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, participants who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those participants would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.