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HIV Clinical Trials

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https://www.readbyqxmd.com/read/28081673/atherogenic-properties-of-ldl-particles-after-switching-from-truvada-or-kivexa-plus-lopinavir-r-to-lamivudine-plus-lopinavir-r-ole-met-substudy
#1
Maria Saumoy, Juan M Tiraboschi, Jordi Ordoñez-Llanos, Esteban Ribera, Pere Domingo, Josep Mallolas, Jordi Curto, Josep M Gatell, Daniel Podzamczer
BACKGROUND: The objective of this study was to determine the impact of tenofovir or abacavir discontinuation on low-density lipoprotein (LDL) phenotype and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in HIV-infected patients treated with lopinavir/ritonavir plus 2 nucleos(t)ide reverse transcriptase inhibitors (NRTI). METHODS: Multicenter, open-label study. Patients were randomized to continue with lopinavir/ritonavir plus 2 NRTI (triple therapy) or to switch to lopinavir/ritonavir plus lamivudine (dual therapy)...
January 12, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28067163/hbv-coinfection-is-associated-with-reduced-cd4-response-to-antiretroviral-treatment-in-pregnancy
#2
Marco Floridia, Giulia Masuelli, Enrica Tamburrini, Arsenio Spinillo, Giuliana Simonazzi, Giovanni Guaraldi, Anna Maria Degli Antoni, Pasquale Martinelli, Vincenzo Portelli, Serena Dalzero, Marina Ravizza
OBJECTIVE: To evaluate the impact of Hepatitis B virus (HBV) coinfection on response to antiretroviral treatment in pregnant women with HIV. METHODS: Retrospective analysis of a large case series of pregnant women with HIV in Italy; outcome measures were CD4 changes, HIV viral load, and main pregnancy outcomes (preterm delivery, low birthweight, intrauterine growth restriction, mode of delivery, and major birth defects). RESULTS: Rate of HBV coinfection among 1462 pregnancies was 12...
January 9, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28067119/efficacy-and-safety-of-unboosting-atazanavir-in-a-randomized-controlled-trial-among-hiv-infected-patients-receiving-tenofovir-df
#3
Marianne Harris, Bruce Ganase, Birgit Watson, Mark W Hull, Silvia A Guillemi, Wendy Zhang, Ramesh Saeedi, P Richard Harrigan
OBJECTIVES: To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF). METHODS: HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone...
January 9, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/27951755/comparative-effectiveness-of-tenofovir-in-hiv-infected-treatment-experienced-patients-systematic-review-and-meta-analysis
#4
Hannah Ewald, Marilia Santini-Oliveira, Julian-Emanuel Bühler, Danielle Vuichard, Stefan Schandelmaier, Marcel Stöckle, Matthias Briel, Heiner C Bucher, Lars G Hemkens
BACKGROUND: Antiretroviral therapy (ART) regimens for HIV infection are frequently changed. We conducted a systematic review of randomized trials (RCTs) on the benefits and harms of switching to tenofovir disoproxil fumarate (TDF)-based regimens in ART-experienced patients. METHODS: We included RCTs in HIV-infected adults comparing switching to a TDF-containing regimen with maintaining or switching to another regimen. We searched MEDLINE, EMBASE, CENTRAL, LILACS, SCI, and the WHO Global Health Library...
December 13, 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27951753/novel-imaging-modalities-for-the-comparison-of-bone-microarchitecture-among-hiv-patients-with-and-without-fractures-a-pilot-study
#5
Darrell H S Tan, Janet Raboud, Leah Szadkowski, Eva Szabo, Hanxian Hu, Queenie Wong, Angela M Cheung, Sharon L Walmsley
BACKGROUND: HIV-infected adults have increased fracture risk. OBJECTIVES: To generate pilot data comparing bone density, structure, and strength between HIV-infected adults with and without a prior fracture. METHODS: Adults with and without a prior fracture after their HIV diagnosis were matched 1:1 based on age, sex, race, and smoking history. Participants underwent dual-energy X-ray absorptiometry (DXA), trabecular bone score (TBS), hip structural analyses (HSA), vertebral fracture assessment (VFA), high-resolution peripheral quantitative tomography (HR-pQCT) and measurement of bone turnover markers...
December 13, 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27846791/clinical-experience-with-dolutegravir-abacavir-lamivudine-in-hiv-hcv-co-infected-patients-treated-with-a-sofosbuvir-based-regimen-safety-and-efficacy
#6
Tamara M Johnson, Raymund Sison, James P Fallon, Prerak P Shukla, Sristi Bhattarai, Herbert Galang, Richard Habeeb, Jihad Slim
BACKGROUND: There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination. METHODS: Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks...
November 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27809711/systematic-review-of-renal-and-bone-safety-of-the-antiretroviral-regimen-efavirenz-emtricitabine-and-tenofovir-disoproxil-fumarate-in-patients-with-hiv-infection
#7
Roger Bedimo, Lisa Rosenblatt, Joel Myers
BACKGROUND: Tenofovir disoproxil fumarate (TDF) is a component of many combinations of antiretroviral treatment (ART) regimens. Although potent and generally well tolerated, TDF may cause renal and bone toxicity. The magnitude of off-target side effects is proposed to be related to tenofovir plasma concentrations, which are affected by food and drug-drug interactions with concomitant antiretrovirals. OBJECTIVE: To perform a systematic literature review and qualitatively report on renal and bone safety outcomes associated with efavirenz (EFV), emtricitabine (FTC), and TDF (EFV+FTC+TDF) ART...
November 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27801628/getting-pregnant-in-hiv-clinical-trials-women-s-choice-and-safety-needs-the-experience-from-the-anrs12169-2lady-and-anrs12286-mobidip-trials
#8
Alexandra Serris, Jacques Zoungrana, Mamadou Diallo, Roselyne Toby, Mireille Mpoudi Ngolle, Sylvie Le Gac, Julie Coutherut, Amandine Cournil, Pierre De Beaudrap, Sinata Koulla-Shiro, Eric Delaporte, Laura Ciaffi
INTRODUCTION: Pregnancy is an exclusion criteria in most clinical trials involving antiretroviral therapy (ART) and modern contraception methods are systematically proposed to women of childbearing age. Nevertheless pregnancies are often observed. Reproductive choices during clinical trials should be understood to adapt interventions to the level of risk for mother and baby safety. Our goal was to describe the reproductive behavior and pregnancy outcomes among HIV-infected women on second-line antiretroviral treatment enrolled in two clinical trials and to compare them with those of HIV-positive women in non-research settings...
November 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27658740/telmisartan-increases-vascular-reparative-capacity-in-older-hiv-infected-adults-a-pilot-study
#9
Jordan E Lake, Sophie Seang, Theodoros Kelesidis, Judith S Currier, Otto O Yang
BACKGROUND: Endothelial progenitor cells (EPCs) are bone marrow-derived cells that contribute to vascular repair. EPCs may be reduced in HIV-infected (HIV+) persons, contributing to cardiovascular disease (CVD). Telmisartan is an angiotensin receptor blocker that increases EPCs in HIV-uninfected adults. OBJECTIVE: To assess telmisartan's effects on EPC number and immunophenotype in older HIV + adults at risk for CVD. METHODS: HIV + persons ≥50 years old with HIV-1 RNA < 50 copies/mL on suppressive antiretroviral therapy and ≥1 CVD risk factor participated in a prospective, open-label, pilot study of oral telmisartan 80 mg daily for 12 weeks...
November 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27561455/increased-homocysteine-plasma-level-is-associated-with-shortened-prothrombin-time-in-hiv-infected-patients
#10
Bernardino Roca, Manuel Roca, Guillermo Girones
OBJECTIVE: To find factors associated with increased homocysteine plasma level in HIV-infected patients. METHODS: Cross-sectional study, carried out as a supplementary task to the standard care of HIV-infected patients. The possible association of increased homocysteine plasma level with blood analyses results was assessed with a multiple linear regression analysis, using the automatic linear modeling available in SPSS version 22. RESULTS: A total of 145 patients were included...
September 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27491797/development-and-psychometric-evaluation-of-a-condom-use-self-efficacy-measure-in-spanish-and-english
#11
Brian E McCabe, Natasha Schaefer Solle, Karina Gattamorta, Natalia Villegas, Rosina Cianelli, Victoria B Mitrani, Nilda Peragallo
BACKGROUND: Condom self-efficacy is an important construct for HIV/STI prevention and intervention. A psychometrically sound measure of the self-efficacy for using condoms that has been designed for Hispanic women to respond in Spanish or English is needed. OBJECTIVES: The goal of this study was to develop and evaluate a brief self-report measure of condom use self-efficacy. METHODS: We developed a 15-item measure of condom use self-efficacy based on expert knowledge of measurement and HIV/STI prevention with Hispanic women using a translation-back translation approach...
September 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27465646/long-term-follow-up-of-hiv-seroconverters-in-microbicide-trials-rationale-study-design-and-challenges-in-mtn-015
#12
Sharon A Riddler, Marla Husnik, Pamina M Gorbach, Lisa Levy, Urvi Parikh, Edward Livant, Arendevi Pather, Bonus Makanani, Felix Muhlanga, Margaret Kasaro, Francis Martinson, Vanessa Elharrar, Jennifer E Balkus
BACKGROUND: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort...
September 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27454119/cytotoxic-chemotherapy-and-the-evolution-of-cellular-and-viral-resistance-to-antiretroviral-therapy-in-hiv-infected-individuals-with-lymphoma
#13
Katie McFaul, Neill Liptrott, Alison Cox, Phillip Martin, Deirdre Egan, Andrew Owen, Sarah Kelly, Zeenat Karolia, Kate Shaw, Mark Bower, Marta Boffito
BACKGROUND: The use of combination antiretroviral therapy (cART) and cytotoxic chemotherapy for HIV-associated lymphoma runs the risks of inducing HIV drug resistance. This study examined two possible mechanisms: altered expression of membrane drug transporter protein (MTP) and acquisition of mutations in pro-viral DNA. METHODS: Expression levels of MTP and pro-viral DNA resistance mutation analysis were performed on peripheral blood mononuclear cells (PBMC) before, during, and after chemotherapy...
September 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27409415/severe-dyslipidemia-and-immune-activation-in-hiv-patients-with-dysglycemia
#14
Changzhong Jin, Shujing Ji, Tiansheng Xie, Stefan Höxtermann, Wolfgang Fuchs, Xiangyun Lu, Haibo Wu, Linfang Cheng, Adriane Skaletz-Rorowski, Norbert H Brockmeyer, Nanping Wu
BACKGROUND AND OBJECTIVE: Diabetes mellitus (DM) is common in human immunodeficiency virus (HIV)-infected patients. However, the relationship between dysglycemia, lipid metabolism, and immune activation in HIV patients is poorly understood. METHODS: We retrospectively analyzed the clinical data of 180 HIV patients, including 153 patients undergoing highly active antiretroviral therapy (HAART) and 27 HAART-naive patients. DM was defined as fasting serum glucose levels ≥126 mg/dl, and impaired fasting glucose (IFG) was defined as serum glucose levels of 101-125 mg/dl at two different time points...
September 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27472067/predictors-of-late-virologic-failure-after-initial-successful-suppression-of-hiv-replication-on-efavirenz-based-antiretroviral-therapy
#15
Isaac Singini, Thomas B Campbell, Laura M Smeaton, Nagalingeswaran Kumarasamy, Alberto La Rosa, Sineenart Taejareonkul, Steven A Safren, Timothy P Flanigan, James G Hakim, Michael D Hughes
BACKGROUND: Practical issues, including cost, hinder implementing virologic monitoring of patients on antiretroviral therapy (ART) in resource-limited settings. We evaluated factors that might guide monitoring frequency and efforts to prevent treatment failure after initial virologic suppression. METHODS: Participants were the 911 HIV-infected antiretroviral-naïve adults with CD4 count <300 cells/μL who started efavirenz-based ART in the international A5175/PEARLS trial and achieved HIV-1 RNA <1000 copies/mL at 24 weeks...
July 29, 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27378421/an-observational-study-on-the-incidence-of-tuberculosis-among-a-cohort-of-hiv-infected-adults-in-a-setting-with-low-prevalence-of-tuberculosis
#16
Kaveh Manavi, James Hodson
BACKGROUND: Tuberculosis (TB) remains a main cause of morbidity and mortality among individuals infected with HIV. We investigated the incidence of TB among a cohort of HIV infected patients attending a setting with low TB burden where screening for latent TB infection is not routinely carried out. METHODS: an observational cohort study on HIV-infected adults attending the HIV clinic at Queen Elizabeth Hospital Birmingham, UK between 1 January 2011 and 30 September 2015...
July 4, 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27347650/characteristics-associated-with-virologic-failure-in-high-risk-hiv-positive-participants-with-prior-failure-a-post-hoc-analysis-of-actg-5251
#17
Gregory K Robbins, Susan E Cohn, Linda J Harrison, Laura Smeaton, Laura Moran, David Rusin, Marjorie Dehlinger, Theresa Flynn, Sara Lammert, Albert W Wu, Steven A Safren, Nancy R Reynolds
UNLABELLED: Patients with prior virologic failure (VF) are at an increased risk of subsequent failure, emergence of resistance, and death. This analysis identifies outcomes and correlates of VF in a high-risk population. METHODS: A5251 was designed to evaluate an enhanced adherence counseling intervention delivered by nurses from a central call site on virologic suppression. Due to slow enrollment, the study was closed prematurely and revised study endpoints were evaluated (week 24 VF (HIV-1 RNA ≥200 copies/ml) and non-perfect adherence (<100% self-reported using both the ACTG adherence questionnaire and visual analog scale (VAS))...
July 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27300696/cxcr4-using-hiv-variants-in-a-cohort-of-black-men-who-have-sex-with-men-hiv-prevention-trials-network-061
#18
Iris Chen, Wei Huang, Matthew B Connor, Arne Frantzell, Vanessa Cummings, Geetha G Beauchamp, Sam Griffith, Sheldon D Fields, Hyman M Scott, Steven Shoptaw, Carlos Del Rio, Manya Magnus, Sharon Mannheimer, Hong-Van Tieu, Darrell P Wheeler, Kenneth H Mayer, Beryl A Koblin, Susan H Eshleman
OBJECTIVE: To evaluate factors associated with HIV tropism among Black men who have sex with men (MSM) in the United States enrolled in a clinical study (HIV Prevention Trials Network 061). METHODS: HIV tropism was analyzed using a phenotypic assay (Trofile assay, Monogram Biosciences). Samples were analyzed from 43 men who were HIV infected at enrollment and reported either exclusive insertive intercourse or exclusive receptive intercourse; samples were also analyzed from 20 men who were HIV uninfected at enrollment and seroconverted during the study...
July 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27294339/effect-of-rosuvastatin-on-plasma-coenzyme-q10-in-hiv-infected-individuals-on-antiretroviral-therapy
#19
Justin T Morrison, Chris T Longenecker, Alison Mittelsteadt, Ying Jiang, Sara M Debanne, Grace A McComsey
BACKGROUND: Coenzyme Q10 (CoQ10) deficiency has been associated with statin-induced myopathy, and supplementation with CoQ10 may reduce inflammation markers. The effects of statins on CoQ10 and its anti-inflammatory properties have not been investigated in HIV-positive patients. OBJECTIVE: The objectives of this study were to examine the effect of rosuvastatin on CoQ10 and CoQ10/LDL ratio over 24-week SATURN-HIV trial, explore the associations between CoQ10 levels and markers of vascular disease, inflammation, and immune activation, and assess whether changes in CoQ10 affected the anti-inflammatory effects of statin therapy or were associated with myalgia symptoms...
July 2016: HIV Clinical Trials
https://www.readbyqxmd.com/read/27267710/can-probiotics-reduce-inflammation-and-enhance-gut-immune-health-in-people-living-with-hiv-study-designs-for-the-probiotic-visbiome-for-inflammation-and-translocation-proov-it-pilot-trials
#20
Connie J Kim, Sharon L Walmsley, Janet M Raboud, Colin Kovacs, Bryan Coburn, Rodney Rousseau, Robert Reinhard, Ron Rosenes, Rupert Kaul
OBJECTIVES: Despite substantial improvements in HIV outcomes with combination antiretroviral therapy (cART), morbidity and mortality remain above population norms. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Since the microbial environment surrounding a CD4 T cell may influence its development and function, we hypothesize that probiotics provided during cART might reduce inflammation and improve gut immune health in HIV-positive treatment-naïve individuals (PROOV IT I) and individuals with suboptimal CD4 recovery on cART (PROOV IT II)...
July 2016: HIV Clinical Trials
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