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HIV Clinical Trials

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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
#1
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/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
#2
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...
March 14, 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
#3
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
https://www.readbyqxmd.com/read/28212601/feasibility-of-identifying-out-of-care-hiv-positive-patients-in-a-hospital-setting-and-enrolling-them-in-a-retention-intervention
#4
Jessica A Davila, Christine Hartman, Jeffrey Cully, Melinda Stanley, K Rivet Amico, Elizabeth Soriano, Sophie Minick, Sarah B May, Thomas P Giordano
BACKGROUND: The hospital setting provides an opportunity to re-engage people living with HIV (PLWH) in HIV care. We developed and implemented a protocol to identify PLWH in a hospital setting. The aim of the current study was to report on our strategy to recruit hospitalized HIV patients into an intervention study, and to report on lessons learned for future studies. METHODS: Our protocol was developed based on experience of our research staff in recruiting HIV patients as well as clinical input from providers and administrators on delivering care in hospitalized settings...
March 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28183221/sofosbuvir-in-the-treatment-of-early-hcv-infection-in-hiv-infected-men
#5
Ahmed El Sayed, Zachary R Barbati, Samuel S Turner, Andrew L Foster, Tristan Morey, Douglas T Dieterich, Daniel S Fierer
BACKGROUND: There is an international epidemic of hepatitis C virus (HCV) infection among HIV-infected men who have sex with men. We previously showed that adding telaprevir to pegylated interferon (IFN) and ribavirin (RBV) both shortened treatment and increased the cure rate of early HCV in these men. Whether shortening treatment of early HCV using IFN-free regimens would be similarly successful has not yet been demonstrated. METHODS: We performed a pilot study of treatment with sofosbuvir (SOF) + RBV for 12 weeks in early genotype 1 HCV infection in HIV-infected men...
March 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28134057/hiv-viral-kinetics-and-t-cell-dynamics-in-antiretroviral-na%C3%A3-ve-persons-starting-an-integrase-strand-transfer-inhibitor-and-protease-inhibitor-regimen
#6
Maile Y Karris, Sonia Jain, Tyler R C Day, Josué Pérez-Santiago, Miguel Goicoechea, Michael P Dubé, Xiaoying Sun, Celsa Spina, Eric S Daar, Richard H Haubrich, Sheldon Morris
BACKGROUND: Nucleos(t)ide reverse transcriptase inhibitor (NRTI)-sparing regimens may potentially minimize antiretroviral (ART) toxicities, but demonstrate mixed efficacy and toxicity results. The impact of an integrase strand transfer inhibitor (INSTI) and protease inhibitor (PI) regimen on HIV viral dynamics and T cell kinetics remains underdescribed. OBJECTIVE: To compare the effect of raltegravir + ritonavir boosted lopinavir (RAL + LPV/r) to efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) on HIV kinetics and T cell dynamics...
March 2017: HIV Clinical Trials
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
#7
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)...
March 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28067163/hbv-coinfection-is-associated-with-reduced-cd4-response-to-antiretroviral-treatment-in-pregnancy
#8
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...
March 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28125951/quality-of-life-improvement-in-hiv-1-patients-treated-with-raltegravir-in-a-real-life-observational-study-racing
#9
Bruno Spire, Lella Nait-Ighil, Pascal Pugliese, Isabelle Poizot-Martin, Vincent Jullien, Anne-Geneviève Marcelin, Eric Billaud
BACKGROUND: Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. METHODS: Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months...
January 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
#10
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 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
#11
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...
January 2017: 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
#12
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...
January 2017: 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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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