HIV Clinical Trials最新文献

{"title":"Systematic review of renal and bone safety of the antiretroviral regimen efavirenz, emtricitabine, and tenofovir disoproxil fumarate in patients with HIV infection","authors":"R. Bedimo, L. Rosenblatt, J. Myers","doi":"10.1080/15284336.2016.1243363","DOIUrl":"https://doi.org/10.1080/15284336.2016.1243363","url":null,"abstract":"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. Methods: Embase and PubMed databases were searched for randomized clinical trials and observational cohort studies reporting on HIV treatment with EFV+FTC+TDF. Relevant articles were hand-searched for renal (Grade 3–4 serum creatinine/estimated glomerular filtration rate elevations, renal adverse events [AEs], discontinuation due to renal AEs, and urinary biomarkers) and bone outcomes (bone mineral density [BMD] reductions, bone turnover markers, and fracture), and results compiled qualitatively. Results: Of 337 retrieved articles, 29 reporting renal and 11 reporting bone outcomes met the review criteria. EFV+FTC+TDF was associated with a low frequency of renal AEs and treatment discontinuations due to renal AEs. Renal AEs were more frequent when TDF was taken with protease inhibitor (PI)- or cobicistat-containing ART. EFV+FTC+TDF was associated with reduced BMD and increased bone turnover markers, but BMD reductions were less than with PI-containing ART. No treatment-related bone fractures were identified. Conclusions: EFV+FTC+TDF appeared to have a more favorable renal safety profile than TDF administered with a PI or cobicistat. BMD decreased with EFV+FTC+TDF, but no treatment-related fractures were identified.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 1","pages":"246 - 266"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1243363","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59913500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Telmisartan increases vascular reparative capacity in older HIV-infected adults: a pilot study","authors":"J. Lake, S. Seang, T. Kelesidis, J. Currier, O. Yang","doi":"10.1080/15284336.2016.1234222","DOIUrl":"https://doi.org/10.1080/15284336.2016.1234222","url":null,"abstract":"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. Using CD34 and CD133 as markers of early maturity and KDR as a marker of endothelial lineage commitment, EPCs were quantified via flow cytometry and defined as viable CD3−/CD33−/CD19−/glycophorin− cells of four immunophenotypes: CD133+/KDR+, CD34+/KDR+, CD34+/CD133+, or CD34+/KDR+/CD133+. The primary endpoint was a 12-week change in EPC subsets (NCT01578772). Results: Seventeen participants (88% men, median age 60 years and peripheral CD4+ T lymphocyte count 625 cells/mm3) enrolled and completed the study. After 6 and 12 weeks of telmisartan, frequencies of all EPC immunophenotypes were higher than baseline (all p < 0.10 except week 12 CD133+/KDR+ EPC, p = 0.13). Participants with lower baseline EPC levels had the largest gains. Additionally, the percentage of CD34+ cells with endothelial commitment (KDR+) increased. Conclusions: Our data suggest that telmisartan use is associated with an increase in circulating EPCs in older HIV + individuals with CVD risk factors. Further controlled studies are needed to assess whether EPC increases translate to a reduction in CVD risk in this population.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 1","pages":"225 - 232"},"PeriodicalIF":0.0,"publicationDate":"2016-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1234222","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59913493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.","authors":"Sharon A Riddler,&nbsp;Marla Husnik,&nbsp;Pamina M Gorbach,&nbsp;Lisa Levy,&nbsp;Urvi Parikh,&nbsp;Edward Livant,&nbsp;Arendevi Pather,&nbsp;Bonus Makanani,&nbsp;Felix Muhlanga,&nbsp;Margaret Kasaro,&nbsp;Francis Martinson,&nbsp;Vanessa Elharrar,&nbsp;Jennifer E Balkus","doi":"10.1080/15284336.2016.1212561","DOIUrl":"https://doi.org/10.1080/15284336.2016.1212561","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing.</p><p><strong>Results: </strong>MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness.</p><p><strong>Conclusions: </strong>Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 5","pages":"204-11"},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1212561","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34708969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and psychometric evaluation of a condom use self-efficacy measure in Spanish and English.","authors":"Brian E McCabe,&nbsp;Natasha Schaefer Solle,&nbsp;Karina Gattamorta,&nbsp;Natalia Villegas,&nbsp;Rosina Cianelli,&nbsp;Victoria B Mitrani,&nbsp;Nilda Peragallo","doi":"10.1080/15284336.2016.1213487","DOIUrl":"https://doi.org/10.1080/15284336.2016.1213487","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>The goal of this study was to develop and evaluate a brief self-report measure of condom use self-efficacy.</p><p><strong>Methods: </strong>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. Participants were 320 Hispanic women from the Southeastern US.</p><p><strong>Results: </strong>Internal consistency of the full measure was 92. A short form of the instrument with a subset of five items also had acceptable internal consistency, alpha = .80, and was significantly correlated with the full scale, rs = .93, p < .001. A single latent factor explained 9-48% of the variation in these items. Evidence of construct validity of the short form was provided by correlations of the scale with two self-report measures of condom use: rs = .34** with condom use, rs = .37** with condom use during vaginal sex.</p><p><strong>Conclusions: </strong>Either the full measure or the five-item measure could be used in studies where condom use is an important behavioral outcome, such as evaluating prevention interventions, with Hispanic women. Future studies should examine the performance of this measure with other groups, including Hispanic men and members of other ethnic and language groups.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 5","pages":"212-7"},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1213487","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34342573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cytotoxic chemotherapy and the evolution of cellular and viral resistance to antiretroviral therapy in HIV- infected individuals with lymphoma.","authors":"Katie McFaul,&nbsp;Neill Liptrott,&nbsp;Alison Cox,&nbsp;Phillip Martin,&nbsp;Deirdre Egan,&nbsp;Andrew Owen,&nbsp;Sarah Kelly,&nbsp;Zeenat Karolia,&nbsp;Kate Shaw,&nbsp;Mark Bower,&nbsp;Marta Boffito","doi":"10.1080/15284336.2016.1210719","DOIUrl":"https://doi.org/10.1080/15284336.2016.1210719","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>Expression levels of MTP and pro-viral DNA resistance mutation analysis were performed on peripheral blood mononuclear cells (PBMC) before, during, and after chemotherapy.</p><p><strong>Results: </strong>Twenty nine patients completed the three time point estimations. There were no significant variations before, during, and after chemotherapy in the expression of four MTPs: ABCB1, ABCC1, ABCC2, and SLCO3A1 (OATP3A1). Pro-viral DNA sequencing revealed that only one patient developed a new nucleos/tide reverse transcriptase inhibitor-associated mutation (184V) during the course of the study, giving a mutation rate of 0.0027 per person per year.</p><p><strong>Conclusions: </strong>In conclusion, concomitant administration of cytotoxic chemotherapy and cART does not induce expression of MTP. Furthermore, no significant changes in viral resistance were observed pre- and post-chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 5","pages":"197-203"},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1210719","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34602082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Severe dyslipidemia and immune activation in HIV patients with dysglycemia.","authors":"Changzhong Jin,&nbsp;Shujing Ji,&nbsp;Tiansheng Xie,&nbsp;Stefan Höxtermann,&nbsp;Wolfgang Fuchs,&nbsp;Xiangyun Lu,&nbsp;Haibo Wu,&nbsp;Linfang Cheng,&nbsp;Adriane Skaletz-Rorowski,&nbsp;Norbert H Brockmeyer,&nbsp;Nanping Wu","doi":"10.1080/15284336.2016.1207297","DOIUrl":"https://doi.org/10.1080/15284336.2016.1207297","url":null,"abstract":"<p><strong>Background and objective: </strong>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.</p><p><strong>Methods: </strong>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. Lipid metabolic indexes were measured. CD4+, CD8+, and CD8+ HLA-DR+ T cells were determined by flow cytometry.</p><p><strong>Results: </strong>IFM and DM percentages were higher in the HAART group than in the HAART-naive group (59.5% vs. 48.1% and 21.6% vs. 7.4%, respectively; p < 0.01). Additionally, DM percentage was high in patients receiving HAART containing protease inhibitors. Serum levels of triglycerides and very low-density lipoprotein cholesterol were higher in IFG and DM HAART patients than in euglycemic HAART patients (p < 0.05). Serum triglyceride levels were higher in HAART-naive DM patients than in other patients (p < 0.05). CD8+ and CD8+ HLA-DR+ cell counts were higher in IFG and DM HAART patients than in euglycemic HAART patients (p < 0.05). Ordinal logistic regression analysis suggested that TRIG, VLDL, CD8, and HAART were predictors of glucose metabolic disorders.</p><p><strong>Conclusion: </strong>HIV patients with hyperglycemia have severe dyslipidemia and immune activation, and HAART is an important impact factor of glucose and lipid metabolic disorders.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 5","pages":"189-96"},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1207297","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34664944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increased homocysteine plasma level is associated with shortened prothrombin time in HIV-infected patients.","authors":"Bernardino Roca,&nbsp;Manuel Roca,&nbsp;Guillermo Girones","doi":"10.1080/15284336.2016.1220712","DOIUrl":"https://doi.org/10.1080/15284336.2016.1220712","url":null,"abstract":"<p><strong>Objective: </strong>To find factors associated with increased homocysteine plasma level in HIV-infected patients.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>A total of 145 patients were included. Creatinine was higher than normal in 7 patients (5%), prothrombin time was shortened in 36 patients (25%), and a monoclonal gammopathy was detected in 2 patients (1%). In the regression analysis, an association was found between high homocysteine plasma level and the following variables: low prothrombin time (β coefficient -0.286, confidence interval -1.1854 to -0.754, p < 0.001), high creatinine (coefficient 9.926, confidence interval 6.351-15.246, p < 0.001), low folic acid (coefficient -0.331, confidence interval -0-483 to -0.187, p < 0.001), and low vitamin B12 (coefficient -0.007, confidence interval -0.01 to -0.001, p = 0.005).</p><p><strong>Conclusion: </strong>An association was found between increased homocysteine plasma level and shortened prothrombin time.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 5","pages":"218-23"},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1220712","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34390796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of rosuvastatin on plasma coenzyme Q10 in HIV-infected individuals on antiretroviral therapy.","authors":"Justin T Morrison, Chris T Longenecker, Alison Mittelsteadt, Ying Jiang, Sara M Debanne, Grace A McComsey","doi":"10.1080/15284336.2016.1184863","DOIUrl":"10.1080/15284336.2016.1184863","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>This was a secondary analysis of the SATURN-HIV trial, a 96-week randomized clinical trial of 10 mg daily rosuvastatin vs. placebo in HIV-infected patients on antiretroviral therapy. We assessed the statin treatment effect on CoQ10 levels and CoQ10/LDL ratios and whether changes in these markers were related to myalgias. Relationships between CoQ10, subclinical vascular disease, and biomarkers of inflammation and immune activation were explored using Spearman correlations and multivariable regression models.</p><p><strong>Results: </strong>Overall, 147 patients were included. Median age was 46 years; 78% were male and 68% African American. At baseline, CoQ10 levels and CoQ10/LDL ratio were modestly correlated with markers of HIV disease, immune activation, and carotid distensibility. After 24 weeks of statin therapy, CoQ10 levels decreased (p = 0.002 for between group difference) and CoQ10/LDL ratio increased (p = 0.036). In the statin treatment arm, we did not find evidence of a relationship between changes in CoQ10 or CoQ10/LDL ration and changes in markers of inflammation or immune activation. There was a borderline statistically significant association between changes in CoQ10 and myalgia symptoms [OR 4.0 per 0.1 mg/L decrease in CoQ10, p = 0.07].</p><p><strong>Conclusion: </strong>Twenty-four weeks of 10 mg daily rosuvastatin decreases CoQ10 concentration and increases CoQ10/LDL ratio in HIV-infected patients on antiretroviral therapy.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 4","pages":"140-6"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4980145/pdf/nihms804030.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34474176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CXCR4-using HIV variants in a cohort of Black men who have sex with men: HIV Prevention Trials Network 061.","authors":"Iris Chen,&nbsp;Wei Huang,&nbsp;Matthew B Connor,&nbsp;Arne Frantzell,&nbsp;Vanessa Cummings,&nbsp;Geetha G Beauchamp,&nbsp;Sam Griffith,&nbsp;Sheldon D Fields,&nbsp;Hyman M Scott,&nbsp;Steven Shoptaw,&nbsp;Carlos Del Rio,&nbsp;Manya Magnus,&nbsp;Sharon Mannheimer,&nbsp;Hong-Van Tieu,&nbsp;Darrell P Wheeler,&nbsp;Kenneth H Mayer,&nbsp;Beryl A Koblin,&nbsp;Susan H Eshleman","doi":"10.1080/15284336.2016.1180771","DOIUrl":"https://doi.org/10.1080/15284336.2016.1180771","url":null,"abstract":"<p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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. Clonal analysis of individual viral variants was performed for seroconverters who had dual/mixed (DM) viruses.</p><p><strong>Results: </strong>DM viruses were detected in samples from 11 (26%) of the 43 HIV-infected men analyzed at the enrollment visit; HIV tropism did not differ between those reporting exclusive insertive vs receptive intercourse. DM viruses were also detected in five (25%) of the 20 seroconverters. DM viruses were associated with lower CD4 cell counts. Seroconverters with DM viruses had dual-tropic viruses only or mixed populations of CCR5- and dual-tropic viruses.</p><p><strong>Conclusions: </strong>DM viruses were frequently detected among Black MSM in this study, including seroconverters. Further studies are needed to understand factors driving transmission and selection of CXCR4- and dual-tropic viruses among Black MSM.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 4","pages":"158-64"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1180771","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34576094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Framingham function overestimates the risk of ischemic heart disease in HIV-infected patients from Barcelona.","authors":"Sabina Herrera,&nbsp;Ana Guelar,&nbsp;Luisa Sorlì,&nbsp;Joan Vila,&nbsp;Ema Molas,&nbsp;María Grau,&nbsp;Jaume Marrugat,&nbsp;Erika Esteve,&nbsp;Roberto Güerri-Fernández,&nbsp;Milagro Montero,&nbsp;Hernando Knobel","doi":"10.1080/15284336.2016.1177266","DOIUrl":"https://doi.org/10.1080/15284336.2016.1177266","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>We carried out a longitudinal study of HIV-infected patients with CVR evaluation in a hospital in Barcelona between 2003 and 2013.</p><p><strong>Statistics: </strong>Risk probability was calculated using the FRAMINGHAM function and REGICOR adaptation to the Spanish population, and individuals were categorized in three groups (low, 0 < 5%; moderate, 5-10%; and high, >10%). For each risk group, the number of events over 10 years was calculated using the Kaplan-Meier method, and the expected number of events was calculated by multiplying the frequency of participants in the group by the mean of the probabilities from the risk function. We used the X(2) goodness-of-fit test to assess agreement between observed and expected.</p><p><strong>Results: </strong>Six hundred and forty-one patients were followed up for a median of 10.2 years, and 20 ischemic heart events (IHE) were observed. The mean (95% CI) number of IHEs per 1000 person-years was 3.7 (2.06-5.27). The estimates from the Framingham and REGICOR functions were 40 and 14 IHEs, respectively. The estimate from the original Framingham function differed significantly from the observed incidence (p < 0.001), whereas that from the REGICOR-adapted function did not (p = 0.15). In terms of the number of cardiovascular events (38 events observed), the REGICOR function significantly underestimated risk (p = 0.01), whereas the estimate from the Framingham function was similar to observed (p:0.93).</p><p><strong>Conclusions: </strong>The FRS significantly overestimates risk of IHE events in our HIV-infected patients, while the REGICOR function is a better predictor of these events. In terms of cardiovascular events, the REGICOR function significantly underestimates risk, whereas the FRS is a better estimator. We recommend using CVR scales and adjusting them to the origin of the population being studied.</p>","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 4","pages":"131-9"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1177266","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34474836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}