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HIV Clinical Trials

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sabina Herrera, Ana Guelar, Luisa Sorlì, Joan Vila, Ema Molas, María Grau, Jaume Marrugat, Erika Esteve, Roberto Güerri-Fernández, Milagro Montero, Hernando Knobel
BACKGROUND: Cardiovascular risk (CVR) assessment helps to identify patients at high CVR. The Framingham CVR score (FRS) is the most widely used methods but may overestimate risk in regions with low incidence of cardiovascular disease. The objective was to compare the 10-year performance of the original and the adapted REGICOR - Framingham CVR functions in HIV-infected individuals. METHODS: We carried out a longitudinal study of HIV-infected patients with CVR evaluation in a hospital in Barcelona between 2003 and 2013...
July 2016: HIV Clinical Trials
T J Barber, G Moyle, A Hill, G Jagjit Singh, A Scourfield, H M Yapa, L Waters, D Asboe, M Boffito, M Nelson
BACKGROUND: Ongoing inflammation in controlled HIV infection contributes to non-AIDS comorbidities. High bilirubin appears to exhibit an anti-inflammatory effect in vivo. We therefore examined whether increased bilirubin in persons with HIV was associated with differences in markers of inflammation and cardiovascular, bone, renal disease, and neurocognitive (NC) impairment. METHODS: This cross-sectional study examined inflammatory markers in individuals with stable HIV infection treated with two nucleoside reverse transcriptase inhibitors and a boosted protease inhibitor...
May 2016: HIV Clinical Trials
Dominic C Chow, Jamie M Kagihara, Guangxiang Zhang, Scott A Souza, Howard N Hodis, Yanjie Li, Brooks I Mitchell, Beau K Nakamoto, Kalpana J Kallianpur, Sheila M Keating, Philip J Norris, Lindsay B Kohorn, Lishomwa C Ndhlovu, Cecilia M Shikuma
BACKGROUND: Inflammation may contribute to cardiovascular disease (CVD) among antiretrovirally suppressed HIV-infected individuals. We assessed relationships of monocyte, CD8 T-cell activation and plasma biomarkers to changes in carotid artery intima-media thickness (CIMT). METHODS: Longitudinal study of HIV-infected subjects ≥40 years and on stable antiretroviral therapy (ART) ≥3 months. Peripheral blood mononuclear cells were immunophenotyped by multiparameteric flow cytometry to quantify classical (CD14(++)CD16(-)), intermediate (CD14(++)CD16(+)), non-classical (CD14(low/+)CD16(++)) and transitional (CD14(+)CD16(-)) monocyte subsets and activated (CD38(+)HLA-DR(+)) CD8(+) T-cells at baseline...
May 2016: HIV Clinical Trials
M Sayan, A Gündüz, G Ersöz, A İnan, A Deveci, G Özgür, F Sargın, G Karagöz, A İnci, D İnan, A Ülçay, I Karaoğlan, S Kaya, S S Kutlu, K Süer, A Çağatay, H Akalın
OBJECTIVES: Integrase strand transfer inhibitor (INSTI) is a new class of antiretroviral (ARV) drugs designed to block the action of the integrase viral enzyme, which is responsible for insertation of the HIV-1 genome into the host DNA. The aim of this study was to evaluate for the first time INSTI resistance mutations in Turkish patients. METHODS: This study was conducted in Turkey, between April 2013 and April 2015 using 169 HIV-1-infected patients (78 ARV naive patients and 91 ARV-experienced patients)...
May 2016: HIV Clinical Trials
Paola Nasta, Dominique Salmon, Antonella d'Arminio Monforte, Jeanne M Pimenta, Carlo Cerini, Mariarosaria Giralda, Maria Winnock, Alessandro Cozzi-Lepri
OBJECTIVE: Safety and tolerability evaluation of adapted dose regimens containing fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis co-infection. METHODS: A retrospective multicohort analysis was conducted. Subjects from three European cohorts who started FPV/r or lopinavir/ritonavir (LPV/r) as a comparator contributed data to a centralized database. Subjects were divided into five groups by treatment regimen and level of hepatic impairment (aspartate aminotransferase [AST] platelet ratio index [APRI] score < or ≥2)...
May 2016: HIV Clinical Trials
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