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HIV Clinical Trials

Mariya V Sivay, Jessica M Fogel, Jing Wang, Yinfeng Zhang, Estelle Piwowar-Manning, William Clarke, Autumn Breaud, Joel Blankson, Erica L Hamilton, Kathleen Kahn, Amanda Selin, F Xavier Gomez-Olive, Catherine MacPhail, James P Hughes, Audrey Pettifor, Susan H Eshleman
BACKGROUND: Some individuals control HIV replication without antiretroviral (ARV) therapy. OBJECTIVE: To analyze viral suppression in young women in rural South Africa enrolled in a trial evaluating a behavioral intervention for HIV prevention. METHODS: Plasma samples were obtained from women ages 13-24 (81 infected at enrollment, 164 seroconverters). ARV testing was performed using an assay that detects 20 ARV drugs. Women were classified as viremic controllers if they were virally suppressed for ≥12 months with no ARV drug use...
December 6, 2018: HIV Clinical Trials
Mela Quirico, Ruggiero Valeria, Montaldo Lorenza, Pisano Umberto, Matta Laura, Pasetto Maria Cristina, Onali Simona, Cacace Enrico, Carta Mauro Giovanni, Barca Lucia, Chessa Luchino
OBJECTIVE: To evaluate whether treatment with 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation in HIV patients following different cART regimens yields normal levels of vitamin D3 and PTH as well as whether changes in bone mineral density are clinically significant. METHODS: Consecutive HIV patients following different cART regimens received 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation...
November 16, 2018: HIV Clinical Trials
Zao Zhang, Glen M Chew, Cecilia M Shikuma, Louie Mar A Gangcuangco, Scott A Souza, Bruce Shiramizu, Beau K Nakamoto, Ting Gong, Santhosh R Mannem, Brooks I Mitchell, Kalpana J Kallianpur, Lishomwa C Ndhlovu, Dominic C Chow
BACKGROUND: Chronic inflammation and immune dysfunction occur in human immunodeficiency virus (HIV)-infection despite stable antiretroviral therapy (ART). Red blood cell distribution width (RDW) has been shown to correlate with markers of inflammation in non-HIV conditions. The study objective was to determine associations between RDW with cellular markers of immune activation and immune dysfunction including soluble inflammatory mediators in ART treated HIV infection. METHODS: We performed a cross-sectional analysis of the Hawaii Aging with HIV-Cardiovascular study...
November 13, 2018: HIV Clinical Trials
Chiara Dentone, Antonio Di Biagio, Alessandro Cozzi Lepri, Daniela Fenoglio, Gilberto Filaci, Miriam Lichtner, Stefania Carrara, Andrea Giacometti, Laura Sighinolfi, Giulia Marchetti, Andrea Antinori, Antonella D'arminio Monforte
BACKGROUND: Limited studies have compared the impact of different antiretroviral regimens on soluble markers of inflammation with discordant results. METHODS: In this prospective study, treatment naïve HIV-1-infected patients were included if they started their current regimen with atazanavir/ritonavir (ATV/r) (N = 73, Group 1) or darunavir/ritonavir (DRV/r) (N = 85, Group 2) plus tenofovir/emtricitabine. The analysis of IL-6, MCP-1, sCD163, VCAM-1, ox-LDL, and adiponectine was performed on two stored plasma samples, the first prior to antiretroviral therapy initiation and the second one year after initiation...
November 13, 2018: HIV Clinical Trials
Michael A Horberg, Allison H Oakes, Leo B Hurley, William J Towner, Chun R Chao, Michael J Silverberg, Jean Q Chantra, Courtney G Ellis, Charles P Quesenberry
BACKGROUND: Raltegravir became the first integrase inhibitor to gain FDA approval; but with limited evidence documenting long-term risks in real world care, especially for major health outcomes of interest. OBJECTIVE: Assess raltegravir safety in clinical practice within an integrated health system. METHODS: We conducted a cohort study of HIV-infected adults within Kaiser Permanente California from 2005 to 2013. We compared patients initiating raltegravir during the study period with two groups; a historical cohort (started new antiretroviral regimen [ART] 2005-2007) and a concurrent cohort that did not initiate raltegravir (2007-2013)...
October 27, 2018: HIV Clinical Trials
Joshua Wynne, Rosemary Muwawu, Michael C Mubiru, Betty Kamira, Doreen Kemigisha, Teopista Nakyanzi, Samuel Kabwigu, Clemensia Nakabiito, Flavia Kiweewa Matovu
BACKGROUND: The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. OBJECTIVE: This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda...
October 27, 2018: HIV Clinical Trials
Luís Fernando Deresz, Cinthia Maria Schöler, Paulo Ivo Homem Júnior de Bittencourt, Marlus Karsten, Maria Letícia Rodrigues Ikeda, Anelise Sonza, Pedro Dal Lago
BACKGROUND: Exercise training has been shown to be an effective strategy to balance oxidative stress status; however, this is underexplored in people living with HIV/AIDS (PLWHA). OBJECTIVE: To evaluate the effects of exercise training on oxidative stress in PLWHA receiving antiretroviral therapy. METHODS: Patients performed 24 sessions (3 times per week, 8 weeks) of either aerobic (AT), resistance (RT), or concurrent training (CT). Glutathione disulphide to glutathione ratio (GSSG/GSH) in circulating erythrocytes and thiobarbituric acid-reactive substances (TBARS) in plasma samples were assessed as oxidative stress markers...
October 27, 2018: HIV Clinical Trials
Álvaro Mena, Purificación Cid, Carlos Dueñas, María Ángeles Garcinuño, Juan Francisco Lorenzo, Luis Margusino, Marina Quiñones, Carmen Grande, Iria Rodríguez-Osorio, Ángeles Castro
OBJECTIVES: Darunavir/ritonavir (DRV/r) in mono or dual therapy has proven efficacy in selected patients. The aim of this study was to evaluate the efficacy of switching from DRV/r to DRV/cobicistat (DRV/c) in patients under mono or dual therapy. METHODS: This was a prospective multicenter cohort study of patients using DRV/r under mono or dual therapy plus lamivudine who changed to DRV/c maintaining the previous regimen. All patients had a controlled HIV viral load (<50 copies/ml) when switched and were examined every 12 weeks...
October 2018: HIV Clinical Trials
Cecilia M Shikuma, Lindsay Kohorn, Robert Paul, Dominic C Chow, Kalpana J Kallianpur, Maegen Walker, Scott Souza, Louie Mar A Gangcuangco, Beau K Nakamoto, Francis D Pien, Timothy Duerler, Linda Castro, Lorna Nagamine, Bruce Soll
The antiretroviral drug efavirenz (EFV) has been linked to disordered sleep and cognitive abnormalities. We examined sleep and cognitive function and subsequent changes following switch to an alternative integrase inhibitor-based regimen. Thirty-two HIV-infected individuals on EFV, emtricitabine, and tenofovir (EFV/FTC/TDF) without traditional risk factors for obstructive sleep apnea (OSA) were randomized 2:1 to switch to elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/COBI/FTC/TDF) or to continue EFV/FTC/TDF therapy for 12 weeks...
August 2018: HIV Clinical Trials
Miranda I Murray, Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Alex R Rinehart, William R Spreen, David A Margolis
BACKGROUND: Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a long-acting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP). OBJECTIVE: We report participant outcomes from the phase IIa ECLAIR study related to tolerability, acceptability, and satisfaction of cabotegravir LA. METHODS: The ECLAIR study ( identifier, NCT02076178) was a randomized, placebo-controlled study in healthy men not at high risk of acquiring HIV-1...
August 2018: HIV Clinical Trials
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
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
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
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
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
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May 17, 2018: HIV Clinical Trials
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
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
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
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
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