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HIV Clinical Trials

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https://www.readbyqxmd.com/read/29770750/addendum
#1
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May 17, 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29770749/rosuvastatin-and-atorvastatin-preserve-renal-function-in-hiv-1-infected-patients-with-chronic-kidney-disease-and-hyperlipidaemia
#2
Leonardo Calza, Vincenzo Colangeli, Marco Borderi, Roberto Manfredi, Lorenzo Marconi, Isabella Bon, Maria Carla Re, Pierluigi Viale
BACKGROUND: Hyperlipidaemia is a risk factor for the progression of chronic kidney disease (CKD), which is a frequent comorbidity in patients with HIV-1 infection, but the renal effects of statins remain unclear. METHODS: We performed an observational, prospective study of HIV-infected patients on suppressive antiretroviral therapy, with CKD and hyperlipidaemia, and starting a lipid-lowering treatment with rosuvastatin, atorvastatin or omega-3 fatty acids. CKD was defined as an estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1...
June 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29688139/a-multi-site-community-randomized-trial-of-community-health-workers-to-provide-counseling-and-support-for-patients-newly-entering-hiv-care-in-rural-ethiopia-study-design-and-baseline-implementation
#3
Alan R Lifson, Sale Workneh, Abera Hailemichael, Richard F MacLehose, Keith J Horvath, Rose Hilk, Lindsey Fabian, Anne Sites, Tibebe Shenie
BACKGROUND: Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. OBJECTIVES: We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. METHODS: Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites...
June 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29676212/pro-140-a-monoclonal-antibody-targeting-ccr5-as-a-long-acting-single-agent-maintenance-therapy-for-hiv-1-infection
#4
Kush Dhody, Nader Pourhassan, Kazem Kazempour, Derry Green, Shide Badri, Hana Mekonnen, Denis Burger, Paul J Maddon
Background PRO 140 is a humanized monoclonal antibody targeting CCR5 with potent antiviral activity in patients with CCR5-tropic HIV-1 infection. In phase 2b studies, we evaluated the long-term efficacy, safety, and tolerability of PRO 140 monotherapy in maintaining viral suppression for over 24 months in patients who were stable on combination antiretroviral therapy on entry into the trials. Methods and Results Forty-one adult patients, infected exclusively with CCR5-tropic HIV-1 with viral loads <50 copies/mL, were switched from daily oral combination ART regimens to weekly PRO 140 monotherapy for 12 weeks...
June 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29663871/design-of-a-randomized-controlled-trial-of-zinc-supplementation-to-improve-markers-of-mortality-and-hiv-disease-progression-in-hiv-positive-drinkers-in-st-petersburg-russia
#5
Natalia Gnatienko, Matthew S Freiberg, Elena Blokhina, Tatiana Yaroslavtseva, Carly Bridden, Debbie M Cheng, Christine E Chaisson, Dmitry Lioznov, Sally Bendiks, Glory Koerbel, Sharon M Coleman, Evgeny Krupitsky, Jeffrey H Samet
Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St...
June 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29629852/raltegravir-versus-lopinavir-ritonavir-for-treatment-of-hiv-infected-late-presenting-pregnant-women
#6
Carlos Brites, Isabella Nóbrega, Estela Luz, Ana Gabriela Travassos, Cynthia Lorenzo, Eduardo M Netto
Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1)...
June 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29770748/the-effect-of-switching-protease-inhibitors-to-raltegravir-on-endothelial-function-in-hiv-infected-patients
#7
Maaike Krikke, Kiki Tesselaar, Guido E L van den Berk, Sigrid A Otto, Laura H Freriks, Steven F L van Lelyveld, Frank J L Visseren, Andy I M Hoepelman, Joop E Arends
Objective Lipid management is one of the cornerstones of cardiovascular risk reduction. Treatment of HIV infection with protease inhibitors (PIs) may cause dyslipidaemia, whilst the integrase inhibitor raltegravir (RAL) has a relatively favorable effect on plasma lipids. We examined the effect of switching from PIs to RAL on endothelial function, and its effect on immunological and inflammatory parameters. Methods We performed a 16-week open-label prospective crossover study: 8 weeks intervention (switch PIs to RAL) and 8 weeks control (unchanged cART regimen)...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29770747/cd16-expressing-monocytes-correlate-with-arterial-stiffness-in-hiv-infected-art-na%C3%A3-ve-men
#8
Ling Luo, Yang Han, Xiaojing Song, Ting Zhu, Yong Zeng, Taisheng Li
Objectives To determine the association of the markers of monocyte activation and arterial stiffness among HIV-infected antiretroviral therapy (ART)-naïve men. Methods Sixty HIV-infected ART-naïve men and 20 HIV-uninfected male controls without symptoms or history of cardiovascular disease were recruited. Pulse wave velocity (PWV) were used as the marker of arterial stiffness and determined using a pulse pressure analyzer. The percentage of CD16-expressing monocytes was used as a marker of monocyte activation...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29566585/evaluation-of-epidemiological-clinical-and-laboratory-features-and-mortality-of-144-hiv-aids-cases-in-turkey
#9
Burcu Ozdemir, Meltem A Yetkin, Aliye Bastug, Ayşe But, Halide Aslaner, Esragul Akinci, Hurrem Bodur
Background The number of HIV/AIDS cases in Turkey is increasing rapidly, as is the number of cases worldwide. The aim of this study is to evaluate the characteristics of the clinical and laboratory findings and epidemiological features of HIV/AIDS patients to obtain useful data on the epidemic type and transmission routes associated with Turkey and to identify risk factors for mortality. Methods The patient records of 144 HIV-infected patients who were admitted to our clinic between 2000 and 2015 were analyzed retrospectively...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29493419/durability-and-tolerability-of-first-line-regimens-including-two-nucleoside-reverse-transcriptase-inhibitors-and-raltegravir-or-ritonavir-boosted-atazanavir-or-darunavir-data-from-the-icona-cohort
#10
Antonella d'Arminio Monforte, Patrizia Lorenzini, Alessandro Cozzi-Lepri, Cristina Mussini, Antonella Castagna, Franco Baldelli, Massimo Puoti, Francesca Vichi, Adelaide Maddaloni, Sergio Lo Caputo, Nicola Gianotti, Andrea Antinori
Background We aimed to mimic the ACTG 5257 trial, comparing raltegravir (RAL), ritonavir-boosted atazavavir (ATV/r) and ritonavir-boosted darunavir (DRV/r) in the observational setting. Methods All the ICONA patients starting a first cART with 2NRTI + ATV/r, DRV/r or RAL were included. Primary end-point was treatment failure, i.e. virological failure (confirmed HIV-RNA > 200copies/mL > 6 months therapy) or discontinuation for any reason of the third drug. Secondary end-points: virological failure50 (50 copies/mL threshold), and discontinuation of the third drug due to intolerance/toxicity...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29493385/use-of-next-generation-sequencing-in-the-chat-study-acute-hcv-in-hiv-effect-of-baseline-resistance-associated-ns3-variants-on-treatment-failure
#11
Gurmit Kaur Jagjit Singh, Steve Kaye, James C Abbott, Christoph Boesecke, Juergen Rockstroh, Myra O McClure, Mark Nelson
Background The epidemic of acute HCV infection among HIV-infected men who have sex with men (MSM) is ongoing. Transmission of drug-resistant variants (DRVs) after HCV treatment failure could pose a major threat to the effectiveness of future therapies. We determined the baseline prevalence of pre-existing DRVs in the HCV NS3 protease gene and their effects on the addition of telaprevir (TVR) to standard pegylated interferon and ribavirin (PEG-IFN/RBV) for acute HCV infection in individuals enrolled in a multicentre randomized controlled trial (2013 and 2014)...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29473487/new-design-development-and-optimization-of-an-in-house-quantitative-taqman-real-time-pcr-assay-for-hiv-1-viral-load-measurement
#12
Hassan Noorbazargan, Seyed Alireza Nadji, Siamak Mirab Samiee, Mahdi Paryan, Samira Mohammadi-Yeganeh
Background Viral load measurement is commonly applicable to monitor HIV infection in patients to determine the number of HIV-RNA in serum samples of individuals. The aim of the present study was to set up a highly specific, sensitive, and reproducible home-brewed Real-time PCR assay based on TaqMan chemistry to quantify HIV-1 RNA genome. Methods In this study, three sets of primer pairs and a TaqMan probe were designed for HIV subtypes conserved sequences. An internal control was included in this assay to evaluate the presence of inhibition...
April 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29400626/short-term-folinic-acid-supplementation-and-aerobic-exercise-improve-vascular-reactivity-in-hiv-infected-individuals
#13
Shana S Grigoletti, Jorge P Ribeiro, Eduardo Sprinz, Paula A B Ribeiro
The aim of this study was to determine the effect of supervised exercise and folinic acid supplementation on endothelial function in HIV-infected individuals. A randomized clinical trial, double blinded, was conducted with 16 HIV-infected individuals, antiretroviral therapy (at least 6 months) with undetectable viral load (<50 copies/mL), and CD4 count > 200 cells/mm3 . The subjects were randomized to aerobic exercise (n = 5) and daily intake for 4 weeks of 5 mg of folinic acid (n = 6) or placebo (n = 5) groups...
February 5, 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29447085/paritaprevir-ritonavir-ombitasvir-plus-dasabuvir-in-hiv-hcv-coinfected-patients-with-genotype-1-in-real-life-practice
#14
Juan A Pineda, Antonio Rivero-Juárez, Ignacio de Los Santos, Antonio Collado, Dolores Merino, Luis E Morano-Amado, María J Ríos, Montserrat Pérez-Pérez, Francisco Téllez, Rosario Palacios, Ana B Pérez, María Mancebo, Antonio Rivero, Juan Macías
Background Data on the efficacy, safety, and concomitant use with other drugs of the combination ritonavir-boosted paritaprevir/ombitasvir plus dasabuvir (PrOD) in HIV/HCV-coinfected patients in real life are limited. The objectives of this study were to analyze these topics in HIV/HCV-coinfected subjects bearing HCV genotype 1 (GT1). Methods One hundred and eighty-two HIV/HCV-coinfected patients with GT1 (87 1a, 71 1b, 23 other) treated with PrOD, plus ribavirin (RBV) in 119 cases, in routine clinical practice were analyzed...
February 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29384717/false-positive-hiv-diagnoses-lessons-from-ugandan-and-russian-research-cohorts
#15
Sharon M Coleman, Natalia Gnatienko, Christine A Lloyd-Travaglini, Michael R Winter, Carly Bridden, Elena Blokhina, Dmitry Lioznov, Julian Adong, Jeffrey H Samet, Teri Liegler, Judith A Hahn
BACKGROUND: Research studies rely on accurate assessment of entry criteria in order to maintain study integrity and participant safety, however, challenges can exist with HIV studies in international settings. OBJECTIVE: Examine the unexpectedly high proportion of study participants with an undetectable HIV viral load found in Ugandan and Russian research cohorts meeting antiretroviral therapy (ART)-naïve entry criteria. METHODS: Russian participants with documented HIV and ART-naïve status were recruited between 2012 and 2015 from clinical and non-clinical sites in St...
February 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29268654/implementation-of-a-prospective-pregnancy-registry-for-antiretroviral-based-hiv-prevention-trials
#16
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...
February 2018: 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
#17
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...
February 2018: 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
#18
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)...
February 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29210627/pharmacokinetic-analysis-of-nevirapine-extended-release-400-mg-once-daily-vs-nevirapine-immediate-release-200-mg-twice-daily-formulation-in-treatment-na%C3%A3-ve-patients-with-hiv-1-infection
#19
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
#20
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
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