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HIV Clinical Trials

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https://www.readbyqxmd.com/read/29268654/implementation-of-a-prospective-pregnancy-registry-for-antiretroviral-based-hiv-prevention-trials
#1
Felix G Mhlanga, Lisa Noguchi, Jennifer E Balkus, Samuel Kabwigu, Rachel Scheckter, Jeanna Piper, Heather Watts, Colin O'Rourke, Kristine Torjesen, Elizabeth R Brown, Sharon L Hillier, Richard Beigi
BACKGROUND: Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. METHODS: The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes...
December 21, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29189101/pharmacokinetics-and-pharmacodynamics-of-the-nucleoside-sparing-dual-regimen-containing-rilpivirine-plus-darunavir-ritonavir-in-treatment-na%C3%A3-ve-hiv-1-infected-individuals
#2
Akil Jackson, Laura Else, Christopher Higgs, Zeenat Karolia, Saye Khoo, David Back, Emma Devitt, Anton Pozniak, Marta Boffito
BACKGROUND: We aimed at investigating the antiviral activity and the pharmacokinetics of the dual antiretroviral (ARV) combination of rilpivirine plus darunavir/ritonavir 25/800/100 mg once-daily in naïve HIV-1-infected individuals (NHII) with different baseline viral loads. SETTINGS: Pharmacokinetic/pharmacodynamics study in ARV-naïve HIV-infected individuals. METHODS: The primary endpoint was the number of NHII with HIV-RNA < 40 copies/mL at week 48...
November 30, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29179644/frequency-and-severity-of-potential-drug-interactions-in-a-cohort-of-hiv-infected-patients-identified-through-a-multidisciplinary-team
#3
E Molas, S Luque, A Retamero, D Echeverría-Esnal, A Guelar, M Montero, R Guerri, L Sorli, E Lerma, J Villar, H Knobel
OBJECTIVES: Interactions between antiretroviral treatment (ART) and comedications are a concern in HIV-infected patients. This study aimed to determine the frequency and severity of potential drug-drug interactions (PDDIs) with ART in our setting. METHODS: Observational study by a multidisciplinary team in 1259 consecutive HIV patients (March 2015-September 2016). Data on demographics, toxic habits, comorbidities, and current ART were collected. A structured questionnaire recorded concomitant medications (including occasional and over-the-counter drugs)...
November 28, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29143565/hiv-1-resistance-rarely-observed-in-subjects-using-darunavir-once-daily-regimens-across-clinical-studies
#4
Erkki Lathouwers, Eric Y Wong, Donghan Luo, Sareh Seyedkazemi, Sandra De Meyer, Kimberley Brown
BACKGROUND: Darunavir 800 mg once daily (QD) is indicated for HIV-1-infected treatment-naïve and treatment-experienced (without darunavir resistance-associated mutations [RAMs]) individuals, and has been evaluated in phase 2/3 studies with durations between 48 and 192 weeks. OBJECTIVE: To summarize the development (or identification) of post-baseline resistance (RAMs and antiretroviral phenotypic susceptibility) among subjects receiving darunavir QD dosing. METHODS: Seven phase 2/3 studies with available genotypes/phenotypes for subjects treated with ritonavir- or cobicistat-boosted darunavir 800 mg QD regimens were assessed: ARTEMIS (NCT00258557; n = 343), GS-US-299-0102 (NCT01565850; n = 153), GS-US-216-0130 (NCT01440569; n = 313), ODIN (NCT00524368; n = 294), INROADS (NCT01199939; n = 54), MONET (NCT00458302; n = 256), and PROTEA (NCT01448707; n = 273)...
November 16, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29210627/pharmacokinetic-analysis-of-nevirapine-extended-release-400%C3%A2-mg-once-daily-vs-nevirapine-immediate-release-200%C3%A2-mg-twice-daily-formulation-in-treatment-na%C3%A3-ve-patients-with-hiv-1-infection
#5
Chan-Loi Yong, Joseph C Gathe, Gabriele Knecht, Catherine Orrell, Josep Mallolas, Daniel Podzamczer, Benoit Trottier, Wei Zhang, John P Sabo, Richard Vinisko, Murray Drulak, Anne-Marie Quinson
BACKGROUND: VERxVE data showed non-inferior virologic efficacy with extended release nevirapine (NVP-XR) dosed 400 mg once daily (QD) versus immediate release nevirapine (NVP-IR) 200 mg twice daily in a double-blind, non-inferiority study in treatment-naïve HIV-1-positive patients. OBJECTIVE: To study the pharmacokinetics (PK) of the NVP formulations and identify possible associations with demographic factors. METHODS: Patients with viral load ≥1000 copies/mL and CD4+ count > 50- <400 cells/mm3 (males) and >50- <250 cells/mm3 (females) at screening received NVP-IR 200 mg QD during a 14-day lead-in and were then stratified by baseline viral load and randomized to NVP-XR or -IR...
November 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29210626/short-term-cost-and-efficiency-analysis-of-raltegravir-versus-atazanavir-ritonavir-or-darunavir-ritonavir-for-treatment-naive-adults-with-hiv-1-infection-in-spain
#6
Ashley E Davis, Anita J Brogan, Bridgett Goodwin, Gonzalo Nocea, Virginia Lozano
INTRODUCTION: The AIDS Clinical Trial Group (ACTG) 5257 clinical trial showed that raltegravir (RAL) was superior to atazanavir/ritonavir (ATV/r) and darunavir/ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir DF (FTC/TDF), in a 96-week composite endpoint combining virologic efficacy and tolerability for treatment-naive adults with HIV-1 infection. This study aimed to estimate the efficiency associated with these three regimens in Spain. METHODS: An economic model was developed to estimate costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating first-line therapy...
November 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29210625/evaluation-of-oral-serum-derived-bovine-immunoglobulins-in-hiv-infected-patients-with-chronic-idiopathic-diarrhea
#7
David M Asmuth, John E Hinkle, Anthony LaMarca, Carl J Fichtenbaum, Ma Somsouk, Netanya S Utay, Audrey L Shaw, Bryon W Petschow, Christopher J Detzel, Eric M Weaver
Objectives To evaluate serum-derived bovine immunoglobulin/protein isolate (SBI) for safety and impact on gastrointestinal (GI) symptoms in HIV patients with chronic idiopathic diarrhea. Methods A multi-center trial comprised of a double-blind, placebo (PBO)-controlled lead-in phase, (participants received PBO or SBI at 2.5 or 5.0 g BID for 4 weeks) followed by a 20-week, PBO-free phase (SBI at either 2.5 or 5.0 g BID). Participants included HIV-infected patients who were virologically suppressed with a history of chronic idiopathic diarrhea, defined as > 3 loose stools per day for ≥ 3 months without an identifiable cause...
November 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29039265/hiv-prevention-trial-design-in-an-era-of-effective-pre-exposure-prophylaxis
#8
Amy Cutrell, Deborah Donnell, David T Dunn, David V Glidden, Anneke Grobler, Brett Hanscom, Britt S Stancil, R Daniel Meyer, Ronnie Wang, Robert L Cuffe
Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist about the diminished protective effect observed in women compared with men and the influence of adherence and risk behaviors on effectiveness in targeted subpopulations. Furthermore, the high prophylactic efficacy of the first PrEP agent, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), presents challenges for demonstrating the efficacy of new candidates...
October 17, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28891788/week-48-resistance-analysis-of-elvitegravir-cobicistat-emtricitabine-tenofovir-df-versus-atazanavir-ritonavir-emtricitabine-tenofovir-df-in-hiv-1-infected-women-waves-study-gs-us-236-0128
#9
Rima Kulkarni, Sally L Hodder, Huyen Cao, Silvia Chang, Michael D Miller, Kirsten L White
Background Women and those with non-B subtype HIV-1 are typically underrepresented in clinical trials. WAVES (GS-US-236-0128) was a double-blind phase 3b study among treatment-naïve HIV-1-infected women that demonstrated that elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF; N = 289) was superior to atazanavir + ritonavir + FTC/TDF (ATV + RTV + FTC/TDF; N = 286) for HIV-1 RNA < 50 copies/mL by FDA snapshot analysis at week 48. Here, we describe resistance development through week 48 in women with virologic failure and determine the impact of pre-existing mutations and HIV-1 subtype on viral suppression...
July 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28828963/soluble-tweak-may-predict-carotid-atherosclerosis-in-treated-hiv-infection
#10
Sahera Dirajlal-Fargo, Abdus Sattar, Manjusha Kulkarni, Nicholas Funderburg, Grace A McComsey
BACKGROUND: Soluble Tumor Necrosis Factor Weak Inducer of Apoptosis (sTWEAK) has been proposed as a novel biomarker of cardiovascular disease risk. This study compares levels of sTWEAK, sCD163 and the sCD163/sTWEAK ratio in HIV-infected and uninfected patients and their associations with cardiovascular and inflammatory factors. METHODS: The data for our analysis come from 274 HIV-infected adults and 59 controls. HIV participants were on stable antiretroviral therapy (ART)...
July 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28720039/the-revamp-trial-to-evaluate-hiv-resistance-testing-in-sub-saharan-africa-a-case-study-in-clinical-trial-design-in-resource-limited-settings-to-optimize-effectiveness-and-cost-effectiveness-estimates
#11
Mark J Siedner, Mwebesa B Bwana, Mahomed-Yunus S Moosa, Michelle Paul, Selvan Pillay, Suzanne McCluskey, Isaac Aturinda, Kevin Ard, Winnie Muyindike, Pravikrishnen Moodley, Jaysingh Brijkumar, Tamlyn Rautenberg, Gavin George, Brent Johnson, Rajesh T Gandhi, Henry Sunpath, Vincent C Marconi
BACKGROUND: In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability. OBJECTIVE: We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. APPROACH: We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women...
July 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28689453/switching-to-the-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-and-tenofovir-df-from-non-nucleoside-reverse-transcriptase-inhibitor-plus-coformulated-emtricitabine-and-tenofovir-df-regimens-week-96-results-of-strategy-nnrti
#12
Anton Pozniak, Jason Flamm, Andrea Antinori, Mark Bloch, Douglas Ward, Juan Berenguer, Pierre Cote, Kristen Andreatta, William Garner, Javier Szwarcberg, Thai Nguyen-Cleary, Damian J McColl, David Piontkowsky
BACKGROUND: HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF). OBJECTIVE: We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen...
July 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28587569/will-cure-trials-introduce-an-uncomfortable-revolution-in-the-field-of-hiv-research
#13
Christel Protière, Marie Préau, Marjolaine Doumergue, Marion Mora, Olivier Lambotte, Bruno Spire, Marie Suzan-Monti
No abstract text is available yet for this article.
June 6, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28555519/simplification-to-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-tenofovir-df-from-multi-tablet-ritonavir-boosted-protease-inhibitor-plus-coformulated-emtricitabine-and-tenofovir-df-regimens-week-96-results-of-strategy-pi
#14
Jose R Arribas, Edwin DeJesus, Jan van Lunzen, Christine Zurawski, Manuela Doroana, William Towner, Adriano Lazzarin, Mark Nelson, Damian McColl, Kristen Andreatta, Raji Swamy, Javier Szwarcberg, Thai Nguyen
BACKGROUND: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills. OBJECTIVE: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens. METHODS: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL)...
May 30, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28599618/hiv-coinfected-patients-respond-worse-to-direct-acting-antiviral-based-therapy-against-chronic-hepatitis-c-in-real-life-than-hcv-monoinfected-individuals-a-prospective-cohort-study
#15
Karin Neukam, Luis E Morano-Amado, Antonio Rivero-Juárez, María Mancebo, Rafael Granados, Francisco Téllez, Antonio Collado, María J Ríos, Ignacio de Los Santos-Gil, Sergio Reus-Bañuls, Francisco Vera-Méndez, Paloma Geijo-Martínez, Marta Montero-Alonso, Marta Suárez-Santamaría, Juan A Pineda
OBJECTIVE: HIV/HCV-coinfected patients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice. PATIENTS AND METHODS: In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included...
May 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28420298/prevalence-of-metabolic-syndrome-in-hiv-infected-patients-naive-to-antiretroviral-therapy-or-receiving-a-first-line-treatment
#16
Leonardo Calza, Vincenzo Colangeli, Eleonora Magistrelli, Nicolo' Rossi, Elena Rosselli Del Turco, Linda Bussini, Marco Borderi, Pierluigi Viale
BACKGROUND: The combination antiretroviral therapy (cART) has dramatically improved the life expectancy of patients with HIV infection, but may lead to several long-term metabolic abnormalities. However, data about the frequency of metabolic syndrome (MS) in HIV-infected people vary considerably across different observational studies. METHODS: The prevalence of MS among HIV-infected patients was evaluated by a cross-sectional study conducted among subjects naive to cART or receiving the first antiretroviral regimen and referring to our Clinics from January 2015 to December 2015...
May 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28385131/virologic-outcomes-in-early-antiretroviral-treatment-hptn-052
#17
Susan H Eshleman, Ethan A Wilson, Xinyi C Zhang, San-San Ou, Estelle Piwowar-Manning, Joseph J Eron, Marybeth McCauley, Theresa Gamble, Joel E Gallant, Mina C Hosseinipour, Nagalingeswaran Kumarasamy, James G Hakim, Ben Kalonga, Jose H Pilotto, Beatriz Grinsztejn, Sheela V Godbole, Nuntisa Chotirosniramit, Breno Riegel Santos, Emily Shava, Lisa A Mills, Ravindre Panchia, Noluthando Mwelase, Kenneth H Mayer, Ying Q Chen, Myron S Cohen, Jessica M Fogel
INTRODUCTION: The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. OBJECTIVE: To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. METHODS: 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses...
May 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28290773/the-hiv-care-cascade-and-sub-analysis-of-those-linked-to-but-not-retained-in-care-the-experience-from-a-tertiary-hiv-referral-service-in-dublin-ireland
#18
P McGettrick, B Ghavami-Kia, W Tinago, A Macken, J O'Halloran, J S Lambert, G Sheehan, P W G Mallon
BACKGROUND: The HIV Care Cascade model can be used to measure how clinical services align with United Nations' (UN) HIV treatment targets. Previous models have highlighted sequential losses at each step of the Cascade with a significant proportion being not retained in care (NRIC). OBJECTIVE: We aimed to assess the feasibility of meeting the UN targets and assess factors associated with, and calculate the true proportion of those, NRIC. METHODS: All people living with HIV who were linked to our service, one of three specialist HIV care providers in Dublin Ireland, from its establishment in 1993 to 1 December 2014, were included in the cohort and were categorized as linked to care, retained in care (RIC), on antiretroviral therapy (on ART), virally suppressed (HIV RNA <40copies/ml), and NRIC...
May 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28303753/efficacy-and-safety-of-emtricitabine-tenofovir-alafenamide-ftc-taf-vs-emtricitabine-tenofovir-disoproxil-fumarate-ftc-tdf-as-a-backbone-for-treatment-of-hiv-1-infection-in-virologically-suppressed-adults-subgroup-analysis-by-third-agent-of-a-randomized-double
#19
Frank A Post, Yazdan Yazdanpanah, Gabriel Schembri, Adriano Lazzarin, Jacques Reynes, Franco Maggiolo, Mingjin Yan, Michael E Abram, Cecilia Tran-Muchowski, Andrew Cheng, Martin S Rhee
BACKGROUND: FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety. OBJECTIVE: To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third agent). METHODS: We conducted a 48-week subgroup analysis based on third agent from a randomized, double blind study in virologically suppressed adults on a FTC/TDF-containing regimen who switched to FTC/TAF vs...
March 17, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28277924/follow-your-heart-development-of-an-evidence-based-campaign-empowering-older-women-with-hiv-to-participate-in-a-large-scale-cardiovascular-disease-prevention-trial
#20
Markella V Zanni, Kathleen Fitch, Corinne Rivard, Laura Sanchez, Pamela S Douglas, Steven Grinspoon, Laura Smeaton, Judith S Currier, Sara E Looby
BACKGROUND: Women's under-representation in HIV and cardiovascular disease (CVD) research suggests a need for novel strategies to ensure robust representation of women in HIV-associated CVD research. OBJECTIVE: To elicit perspectives on CVD research participation among a community-sample of women with or at risk for HIV, and to apply acquired insights toward the development of an evidence-based campaign empowering older women with HIV to participate in a large-scale CVD prevention trial...
March 2017: HIV Clinical Trials
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