750 results match your criteria HIV Clinical Trials[Journal]


Durability of dolutegravir plus boosted darunavir as salvage or simplification of salvage regimens in HIV-1 infected, highly treatment-experienced subjects.

HIV Clin Trials 2018 12;19(6):242-248

a 1st Division of Infectious Diseases , ASST Fatebenefratelli-Sacco , Milano , Italy.

Background: Dolutegravir (DTG) plus boosted darunavir (bDRV) is a compact, adherence-friendly salvage regimen with the highest genetic barrier to HIV-1 resistance.

Objective: Aim of the present study is to assess the long term (96-week) safety and efficacy of DTG + bDRV in a of multidrug-experienced HIV-1 infected patients, simplifying or building rescue regimens.

Methods: All HIV-1-infected subjects from eleven Italian centers switched to DTG + bDRV between March 2014 and September 2015 were included and followed for minimum 96 weeks. Read More

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http://dx.doi.org/10.1080/15284336.2018.1550290DOI Listing
December 2018
3 Reads

Impact of CD4+ blood cell count and HIV viral load on treatment response with direct acting antivirals in HIV and HCV coinfected patients: insights from the German Hepatitis C-Registry.

HIV Clin Trials 2018 12;19(6):225-234

a Department of Medicine I , University Hospital Bonn , Bonn , Germany.

Background: Direct-acting antivirals (DAAs) lead to high cure rates of Hepatitis C Virus (HCV) infections in HIV/HCV coinfected patients. Recent data suggest that treatment failures occur more often in HIV/HCV coinfected persons.

Objective: We aimed to identify risk factors for treatment failure in coinfected patients. Read More

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http://dx.doi.org/10.1080/15284336.2018.1538193DOI Listing
December 2018
4 Reads

Participant characteristics and clinical trial decision-making factors in AIDS malignancy consortium treatment trials for HIV-infected persons with cancer (AMC #S006).

HIV Clin Trials 2018 12;19(6):235-241

d AIDS Malignancy Center Statistical Center , University of Arkansas for Medical Sciences , Little Rock , AR, USA.

Background: Overall, people living with HIV/AIDS (PLWHA) are living longer, but compared with the general population, they are at elevated risk for numerous AIDS-defining and non-AIDS-defining cancers. The AIDS Malignancy Consortium (AMC) is dedicated to conducting clinical trials aimed at prevention and treatment of cancers among PLWHA.

Objective: To examine patient-level characteristics and perceptions that influence decision-making regarding AMC treatment trial participation. Read More

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http://dx.doi.org/10.1080/15284336.2018.1537349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6428211PMC
December 2018

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

HIV Clin Trials 2018 12;19(6):209-224

a Division of Infectious Diseases, Department of Medicine , David Geffen School of Medicine at the University of California, Los Angeles , Los Angeles , CA , USA.

Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery.

Methods: Women with pre-ART CD4+ cell counts ≥350 cells/mm who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Read More

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http://dx.doi.org/10.1080/15284336.2018.1537327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6428202PMC
December 2018
1 Read

Darunavir/cobicistat maintains the effectiveness of darunavir/ritonavir in HIV-infected patients under mono or dual therapy.

HIV Clin Trials 2018 10 3;19(5):197-201. Epub 2019 Jan 3.

a Grupo de Virología Clínica , Instituto de Investigación Biomédica de A Coruña (INIBIC)-Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Universidade da Coruña (UDC) , A Coruña , Spain.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1513974DOI Listing
October 2018
8 Reads

Natural control of HIV infection in young women in South Africa: HPTN 068.

HIV Clin Trials 2018 10 6;19(5):202-208. Epub 2018 Dec 6.

a Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.

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). Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
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http://dx.doi.org/10.1080/15284336.2018.1531534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6442735PMC
October 2018
12 Reads

Sleep and neuropsychological performance in HIV+ subjects on efavirenz-based therapy and response to switch in therapy.

HIV Clin Trials 2018 08 19;19(4):139-147. Epub 2018 Nov 19.

a John A. Burns School of Medicine, University of Hawaii , Honolulu , Hawaii , USA.

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. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
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http://dx.doi.org/10.1080/15284336.2018.1511348DOI Listing
August 2018
21 Reads

Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial.

HIV Clin Trials 2018 08 16;19(4):129-138. Epub 2018 Nov 16.

h ViiV Healthcare , Research Triangle Park , NC , USA.

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 (ClinicalTrials. Read More

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http://dx.doi.org/10.1080/15284336.2018.1511346DOI Listing
August 2018
12 Reads

Bone mass preservation with high-dose cholecalciferol and dietary calcium in HIV patients following antiretroviral therapy. Is it possible?

HIV Clin Trials 2018 10 16;19(5):188-196. Epub 2018 Nov 16.

a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.

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. The participants underwent BMD assessment via dual energy X-ray absorptiometry of the spine and hip at baseline (T0) and after 24 months (T1). Read More

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http://dx.doi.org/10.1080/15284336.2018.1525841DOI Listing
October 2018
4 Reads

Red blood cell distribution width as an easily measurable biomarker of persistent inflammation and T cell dysregulation in antiretrovirally treated HIV-infected adults.

HIV Clin Trials 2018 10 13;19(5):172-176. Epub 2018 Nov 13.

a Hawaii Center for AIDS, University of Hawaii John A. Burns School of Medicine , Honolulu , HI , USA.

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. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
Publisher Site
http://dx.doi.org/10.1080/15284336.2018.1514821DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324948PMC
October 2018
7 Reads

Inflammatory effects of atazanavir/ritonavir versus darunavir/ritonavir in treatment naïve, HIV-1-infected patients.

HIV Clin Trials 2018 08 13;19(4):158-162. Epub 2018 Nov 13.

j Clinica di Malattie Infettive , San Paolo Hospital, University of Milan , Milan , Italy.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1488453DOI Listing
August 2018
4 Reads

Association of raltegravir use with long-term health outcomes in HIV-infected patients: an observational post-licensure safety study in a large integrated healthcare system.

HIV Clin Trials 2018 10 27;19(5):177-187. Epub 2018 Oct 27.

c Division of Research , Kaiser Permanente Northern California , Oakland , CA , USA.

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. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
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http://dx.doi.org/10.1080/15284336.2018.1523826DOI Listing
October 2018
29 Reads

Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study.

HIV Clin Trials 2018 10 27;19(5):165-171. Epub 2018 Oct 27.

b Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.

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.

Methods: Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
Publisher Site
http://dx.doi.org/10.1080/15284336.2018.1513711DOI Listing
October 2018
14 Reads

Exercise training reduces oxidative stress in people living with HIV/AIDS: a pilot study.

HIV Clin Trials 2018 08 27;19(4):152-157. Epub 2018 Oct 27.

a Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) , Porto Alegre , RS , Brazil.

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). Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2018.1
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http://dx.doi.org/10.1080/15284336.2018.1481247DOI Listing
August 2018
19 Reads
2.141 Impact Factor

Addendum.

Authors:

HIV Clin Trials 2018 08 17;19(4):163. Epub 2018 May 17.

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http://dx.doi.org/10.1080/15284336.2018.1436794DOI Listing
August 2018
2 Reads

Rosuvastatin and atorvastatin preserve renal function in HIV-1-infected patients with chronic kidney disease and hyperlipidaemia.

HIV Clin Trials 2018 06;19(3):120-128

a Department of Medical and Surgical Sciences, Clinic of Infectious Diseases , "Alma Mater Studiorum" University of Bologna, S. Orsola-Malpighi Hospital , Bologna , Italy.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1468676DOI Listing
June 2018
3 Reads

The effect of switching protease inhibitors to raltegravir on endothelial function, in HIV-infected patients.

HIV Clin Trials 2018 04;19(2):75-83

a Department of Internal Medicine and Infectious Diseases , University Medical Centre Utrecht , Utrecht , The Netherlands.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1455366DOI Listing
April 2018
8 Reads

CD16-expressing monocytes correlate with arterial stiffness in HIV-infected ART-naïve men.

HIV Clin Trials 2018 04;19(2):39-45

a Department of Infectious Diseases , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences , Beijing , China.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1437863DOI Listing
April 2018
10 Reads

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

HIV Clin Trials 2018 06 24;19(3):112-119. Epub 2018 Apr 24.

b Ethiopian Office , National Alliance of State and Territorial AIDS Directors , Addis Ababa , Ethiopia.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1461999DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082124PMC
June 2018
3 Reads

PRO 140, a monoclonal antibody targeting CCR5, as a long-acting, single-agent maintenance therapy for HIV-1 infection.

HIV Clin Trials 2018 06 20;19(3):85-93. Epub 2018 Apr 20.

c Maddon Advisors LLC , Scarsdale , NY , USA.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1452842DOI Listing
June 2018
7 Reads

Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

HIV Clin Trials 2018 06 17;19(3):101-111. Epub 2018 Apr 17.

i Department of Medicine, Section of General Internal Medicine, School of Medicine/Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit , Boston University , Boston , MA , USA.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1459344DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5957784PMC
June 2018
9 Reads

Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women.

HIV Clin Trials 2018 06 9;19(3):94-100. Epub 2018 Apr 9.

a LAPI - Laboratório de Pesquisa em Infectologia , Comlexo Hospitalar Prof. Edgard Santos, Universidade Federal da Bahia , Salvador , Brazil.

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). Read More

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http://dx.doi.org/10.1080/15284336.2018.1459343DOI Listing
June 2018
6 Reads

Evaluation of epidemiological, clinical, and laboratory features and mortality of 144 HIV/AIDS cases in Turkey.

HIV Clin Trials 2018 04 22;19(2):69-74. Epub 2018 Mar 22.

a Department Of Infectious Diseases and Clinical Microbiology , Ankara Numune Training and Research Hospital , Ankara , Turkey.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1453990DOI Listing
April 2018
7 Reads

Durability and tolerability of first-line regimens including two nucleoside reverse transcriptase inhibitors and raltegravir or ritonavir boosted-atazanavir or -darunavir: data from the ICONA Cohort.

HIV Clin Trials 2018 04 1;19(2):52-60. Epub 2018 Mar 1.

b HIV/AIDS Clinical Department , National Institute for Infectious Diseases "Lazzaro Spallanzani" , Rome , Italy.

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. Read More

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http://dx.doi.org/10.1080/15284336.2018.1440691DOI Listing
April 2018
8 Reads

Use of next-generation sequencing in the CHAT study (acute HCV in HIV): effect of baseline resistance-associated NS3 variants on treatment failure.

HIV Clin Trials 2018 04 1;19(2):46-51. Epub 2018 Mar 1.

a Department of HIV and Sexual Health , Chelsea and Westminster Hospital NHS Foundation Trust , London , UK.

Background The epidemic of acute HCV infection among HIV-infected men who have sex with men (MSM) is ongoing. Transmission of drug-resistant variants (DRVs) after HCV treatment failure could pose a major threat to the effectiveness of future therapies. We determined the baseline prevalence of pre-existing DRVs in the HCV NS3 protease gene and their effects on the addition of telaprevir (TVR) to standard pegylated interferon and ribavirin (PEG-IFN/RBV) for acute HCV infection in individuals enrolled in a multicentre randomized controlled trial (2013 and 2014). Read More

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http://dx.doi.org/10.1080/15284336.2018.1439714DOI Listing
April 2018
20 Reads

New design, development, and optimization of an in-house quantitative TaqMan Real-time PCR assay for HIV-1 viral load measurement.

HIV Clin Trials 2018 04 23;19(2):61-68. Epub 2018 Feb 23.

e Cellular and Molecular Biology Research Center , Shahid Beheshti University of Medical Sciences , Tehran , Iran.

Background Viral load measurement is commonly applicable to monitor HIV infection in patients to determine the number of HIV-RNA in serum samples of individuals. The aim of the present study was to set up a highly specific, sensitive, and reproducible home-brewed Real-time PCR assay based on TaqMan chemistry to quantify HIV-1 RNA genome. Methods In this study, three sets of primer pairs and a TaqMan probe were designed for HIV subtypes conserved sequences. Read More

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http://dx.doi.org/10.1080/15284336.2018.1440991DOI Listing
April 2018
8 Reads
2.141 Impact Factor

Paritaprevir/ritonavir/ombitasvir plus dasabuvir in HIV/HCV-coinfected patients with genotype 1 in real-life practice.

HIV Clin Trials 2018 02 15;19(1):23-30. Epub 2018 Feb 15.

a Unit of Infectious Diseases and Microbiology , Hospital Universitario de Valme , Seville , Spain.

Background Data on the efficacy, safety, and concomitant use with other drugs of the combination ritonavir-boosted paritaprevir/ombitasvir plus dasabuvir (PrOD) in HIV/HCV-coinfected patients in real life are limited. The objectives of this study were to analyze these topics in HIV/HCV-coinfected subjects bearing HCV genotype 1 (GT1). Methods One hundred and eighty-two HIV/HCV-coinfected patients with GT1 (87 1a, 71 1b, 23 other) treated with PrOD, plus ribavirin (RBV) in 119 cases, in routine clinical practice were analyzed. Read More

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http://dx.doi.org/10.1080/15284336.2018.1436637DOI Listing
February 2018
16 Reads
2.140 Impact Factor

Short-term folinic acid supplementation and aerobic exercise improve vascular reactivity in HIV-infected individuals.

HIV Clin Trials 2018 08 5;19(4):148-151. Epub 2018 Feb 5.

a Exercise Pathophysiology Research Laboratory , Hospital de Clínicas de Porto Alegre , Porto Alegre , Brazil.

The aim of this study was to determine the effect of supervised exercise and folinic acid supplementation on endothelial function in HIV-infected individuals. A randomized clinical trial, double blinded, was conducted with 16 HIV-infected individuals, antiretroviral therapy (at least 6 months) with undetectable viral load (<50 copies/mL), and CD4 count > 200 cells/mm. The subjects were randomized to aerobic exercise (n = 5) and daily intake for 4 weeks of 5 mg of folinic acid (n = 6) or placebo (n = 5) groups. Read More

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http://dx.doi.org/10.1080/15284336.2018.1433769DOI Listing
August 2018
2 Reads

False-positive HIV diagnoses: lessons from Ugandan and Russian research cohorts.

HIV Clin Trials 2018 02 31;19(1):15-22. Epub 2018 Jan 31.

f Department of Medicine , University of California , San Francisco , CA , USA.

Background: Research studies rely on accurate assessment of entry criteria in order to maintain study integrity and participant safety, however, challenges can exist with HIV studies in international settings.

Objective: Examine the unexpectedly high proportion of study participants with an undetectable HIV viral load found in Ugandan and Russian research cohorts meeting antiretroviral therapy (ART)-naïve entry criteria.

Methods: Russian participants with documented HIV and ART-naïve status were recruited between 2012 and 2015 from clinical and non-clinical sites in St. Read More

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http://dx.doi.org/10.1080/15284336.2018.1429846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5949866PMC
February 2018
6 Reads

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

HIV Clin Trials 2018 02 21;19(1):8-14. Epub 2017 Dec 21.

l Department of OB/GYN/RS , Magee-Womens Hospital of UPMC , Pittsburgh , PA , USA.

Background: Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials.

Methods: The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Read More

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http://dx.doi.org/10.1080/15284336.2017.1411419DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5995113PMC
February 2018
16 Reads

Pharmacokinetic analysis of nevirapine extended release 400 mg once daily vs nevirapine immediate release 200 mg twice daily formulation in treatment-naïve patients with HIV-1 infection.

HIV Clin Trials 2017 Nov-Dec;18(5-6):189-195

a Boehringer Ingelheim Pharmaceuticals, Inc. , Ridgefield , CT , USA.

Background: VERxVE data showed non-inferior virologic efficacy with extended release nevirapine (NVP-XR) dosed 400 mg once daily (QD) versus immediate release nevirapine (NVP-IR) 200 mg twice daily in a double-blind, non-inferiority study in treatment-naïve HIV-1-positive patients.

Objective: To study the pharmacokinetics (PK) of the NVP formulations and identify possible associations with demographic factors.

Methods: Patients with viral load ≥1000 copies/mL and CD4+ count > 50- <400 cells/mm (males) and >50- <250 cells/mm (females) at screening received NVP-IR 200 mg QD during a 14-day lead-in and were then stratified by baseline viral load and randomized to NVP-XR or -IR. Read More

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http://dx.doi.org/10.1080/15284336.2017.1386811DOI Listing
July 2018
7 Reads

Short-term cost and efficiency analysis of raltegravir versus atazanavir/ritonavir or darunavir/ritonavir for treatment-naive adults with HIV-1 infection in Spain.

HIV Clin Trials 2017 Nov-Dec;18(5-6):214-222

c Merck Sharp & Dohme , Madrid , Spain.

Introduction: The AIDS Clinical Trial Group (ACTG) 5257 clinical trial showed that raltegravir (RAL) was superior to atazanavir/ritonavir (ATV/r) and darunavir/ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir DF (FTC/TDF), in a 96-week composite endpoint combining virologic efficacy and tolerability for treatment-naive adults with HIV-1 infection. This study aimed to estimate the efficiency associated with these three regimens in Spain.

Methods: An economic model was developed to estimate costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating first-line therapy. Read More

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http://dx.doi.org/10.1080/15284336.2017.1402144DOI Listing
July 2018
5 Reads

Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea.

HIV Clin Trials 2017 Nov-Dec;18(5-6):205-213

g Entera Health, Inc. , Cary , NC , USA.

Objectives To evaluate serum-derived bovine immunoglobulin/protein isolate (SBI) for safety and impact on gastrointestinal (GI) symptoms in HIV patients with chronic idiopathic diarrhea. Methods A multi-center trial comprised of a double-blind, placebo (PBO)-controlled lead-in phase, (participants received PBO or SBI at 2.5 or 5. Read More

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http://dx.doi.org/10.1080/15284336.2017.1401256DOI Listing
July 2018
74 Reads

Pharmacokinetics and pharmacodynamics of the nucleoside sparing dual regimen containing rilpivirine plus darunavir/ritonavir in treatment-naïve HIV-1-infected individuals.

HIV Clin Trials 2018 02 30;19(1):31-37. Epub 2017 Nov 30.

a St Stephen's Centre, Chelsea and Westminster Hospital , London , UK.

Background: We aimed at investigating the antiviral activity and the pharmacokinetics of the dual antiretroviral (ARV) combination of rilpivirine plus darunavir/ritonavir 25/800/100 mg once-daily in naïve HIV-1-infected individuals (NHII) with different baseline viral loads.

Settings: Pharmacokinetic/pharmacodynamics study in ARV-naïve HIV-infected individuals.

Methods: The primary endpoint was the number of NHII with HIV-RNA < 40 copies/mL at week 48. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2017.1
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http://dx.doi.org/10.1080/15284336.2017.1408928DOI Listing
February 2018
6 Reads

Frequency and severity of potential drug interactions in a cohort of HIV-infected patients Identified through a Multidisciplinary team.

HIV Clin Trials 2018 02 28;19(1):1-7. Epub 2017 Nov 28.

a Infectious Diseases Department, Hospital del Mar, Department of Medicine , Universitat Autònoma de Barcelona , Barcelona , Spain.

Objectives: Interactions between antiretroviral treatment (ART) and comedications are a concern in HIV-infected patients. This study aimed to determine the frequency and severity of potential drug-drug interactions (PDDIs) with ART in our setting.

Methods: Observational study by a multidisciplinary team in 1259 consecutive HIV patients (March 2015-September 2016). Read More

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http://dx.doi.org/10.1080/15284336.2017.1404690DOI Listing
February 2018
3 Reads

HIV-1 resistance rarely observed in patients using darunavir once-daily regimens across clinical studies.

HIV Clin Trials 2017 Nov-Dec;18(5-6):196-204. Epub 2017 Nov 16.

b Janssen Scientific Affairs, LLC , Titusville , NJ , USA.

Background: Darunavir 800 mg once daily (QD) is indicated for HIV-1-infected treatment-naïve and treatment-experienced (without darunavir resistance-associated mutations [RAMs]) individuals, and has been evaluated in phase 2/3 studies with durations between 48 and 192 weeks.

Objective: To summarize the development (or identification) of post-baseline resistance (RAMs and antiretroviral phenotypic susceptibility) among patients receiving darunavir QD dosing.

Methods: Seven phase 2/3 studies with available genotypes/phenotypes for subjects treated with ritonavir- or cobicistat-boosted darunavir 800 mg QD regimens were assessed: ARTEMIS (NCT00258557; n = 343), GS-US-299-0102 (NCT01565850; n = 153), GS-US-216-0130 (NCT01440569; n = 313), ODIN (NCT00524368; n = 294), INROADS (NCT01199939; n = 54), MONET (NCT00458302; n = 256), and PROTEA (NCT01448707; n = 273). Read More

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http://dx.doi.org/10.1080/15284336.2017.1387690DOI Listing
July 2018
17 Reads

HIV prevention trial design in an era of effective pre-exposure prophylaxis.

HIV Clin Trials 2017 Nov-Dec;18(5-6):177-188. Epub 2017 Oct 17.

i ViiV Healthcare , Middlesex , UK.

Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist about the diminished protective effect observed in women compared with men and the influence of adherence and risk behaviors on effectiveness in targeted subpopulations. Furthermore, the high prophylactic efficacy of the first PrEP agent, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), presents challenges for demonstrating the efficacy of new candidates. Read More

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http://dx.doi.org/10.1080/15284336.2017.1379676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6084772PMC
July 2018
7 Reads

Week 48 resistance analysis of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF versus Atazanavir + Ritonavir + Emtricitabine/Tenofovir DF in HIV-1 infected women (WAVES study GS-US-236-0128).

HIV Clin Trials 2017 07;18(4):164-173

a Clinical Virology , Gilead Sciences, Inc. , Foster City , CA , USA.

Background Women and those with non-B subtype HIV-1 are typically underrepresented in clinical trials. WAVES (GS-US-236-0128) was a double-blind phase 3b study among treatment-naïve HIV-1-infected women that demonstrated that elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF; N = 289) was superior to atazanavir + ritonavir + FTC/TDF (ATV + RTV + FTC/TDF; N = 286) for HIV-1 RNA < 50 copies/mL by FDA snapshot analysis at week 48. Here, we describe resistance development through week 48 in women with virologic failure and determine the impact of pre-existing mutations and HIV-1 subtype on viral suppression. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2017.1
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http://dx.doi.org/10.1080/15284336.2017.1370059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5942200PMC
July 2017
60 Reads

Soluble TWEAK may predict carotid atherosclerosis in treated HIV infection.

HIV Clin Trials 2017 07 22;18(4):156-163. Epub 2017 Aug 22.

a Department of Pediatrics , Case Western Reserve University , Cleveland , OH , USA.

Background: Soluble Tumor Necrosis Factor Weak Inducer of Apoptosis (sTWEAK) has been proposed as a novel biomarker of cardiovascular disease risk. This study compares levels of sTWEAK, sCD163 and the sCD163/sTWEAK ratio in HIV-infected and uninfected patients and their associations with cardiovascular and inflammatory factors.

Methods: The data for our analysis come from 274 HIV-infected adults and 59 controls. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2017.1
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http://dx.doi.org/10.1080/15284336.2017.1366001DOI Listing
July 2017
20 Reads

The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates.

HIV Clin Trials 2017 07 18;18(4):149-155. Epub 2017 Jul 18.

d Department of Medicine , Emory University , Atlanta , GA , USA.

Background: In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability.

Objective: We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. Read More

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http://dx.doi.org/10.1080/15284336.2017.1349028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5598555PMC
July 2017
29 Reads

Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI.

HIV Clin Trials 2017 07 9;18(4):141-148. Epub 2017 Jul 9.

h Gilead Sciences, Inc. , Foster City , CA , USA.

Background: HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF).

Objective: We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen.

Methods: STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA < 50 copies/mL) on an NNRTI + TVD regimen. Read More

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http://dx.doi.org/10.1080/15284336.2017.1338844DOI Listing
July 2017
13 Reads

HIV-coinfected patients respond worse to direct-acting antiviral-based therapy against chronic hepatitis C in real life than HCV-monoinfected individuals: a prospective cohort study.

HIV Clin Trials 2017 05;18(3):126-134

a Unit of Infectious Diseases and Microbiology , Hospital Universitario de Valme , Seville , Spain.

Objective: HIV/HCV-coinfected patients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice.

Patients And Methods: In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included. Read More

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https://www.tandfonline.com/doi/full/10.1080/15284336.2017.1
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http://dx.doi.org/10.1080/15284336.2017.1330801DOI Listing
May 2017
52 Reads

Will CURE trials introduce an uncomfortable revolution in the field of HIV research?

HIV Clin Trials 2017 07 6;18(4):174-175. Epub 2017 Jun 6.

a Aix-Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale , Marseille , France.

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http://dx.doi.org/10.1080/15284336.2017.1331603DOI Listing
July 2017
12 Reads

Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI.

HIV Clin Trials 2017 05 30;18(3):118-125. Epub 2017 May 30.

i Gilead Sciences, Inc., Foster City , CA , USA.

Background: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.

Objective: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens.

Methods: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Read More

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http://dx.doi.org/10.1080/15284336.2017.1330440DOI Listing
May 2017
18 Reads

Prevalence of metabolic syndrome in HIV-infected patients naive to antiretroviral therapy or receiving a first-line treatment.

HIV Clin Trials 2017 05 19;18(3):110-117. Epub 2017 Apr 19.

a Clinics of Infectious Diseases, Department of Medical and Surgical Sciences , S.Orsola-Malpighi Hospital, "Alma Mater Studiorum" University of Bologna , Bologna , Italy.

Background: The combination antiretroviral therapy (cART) has dramatically improved the life expectancy of patients with HIV infection, but may lead to several long-term metabolic abnormalities. However, data about the frequency of metabolic syndrome (MS) in HIV-infected people vary considerably across different observational studies.

Methods: The prevalence of MS among HIV-infected patients was evaluated by a cross-sectional study conducted among subjects naive to cART or receiving the first antiretroviral regimen and referring to our Clinics from January 2015 to December 2015. Read More

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http://dx.doi.org/10.1080/15284336.2017.1311502DOI Listing
May 2017
24 Reads

Virologic outcomes in early antiretroviral treatment: HPTN 052.

HIV Clin Trials 2017 05 7;18(3):100-109. Epub 2017 Apr 7.

a Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.

Introduction: The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure.

Objective: To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. Read More

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http://dx.doi.org/10.1080/15284336.2017.1311056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633001PMC
May 2017
40 Reads

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-blind, active-controlled phase 3 trial.

HIV Clin Trials 2017 05 17;18(3):135-140. Epub 2017 Mar 17.

g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.

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). Read More

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http://dx.doi.org/10.1080/15284336.2017.1291867DOI Listing
May 2017
24 Reads

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.

HIV Clin Trials 2017 05 14;18(3):93-99. Epub 2017 Mar 14.

a HIV Molecular Research Group , School of Medicine, University College Dublin , Dublin , Ireland.

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. Read More

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http://dx.doi.org/10.1080/15284336.2017.1298317DOI Listing
May 2017
5 Reads

Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial.

HIV Clin Trials 2017 03;18(2):83-91

a Program in Nutritional Metabolism , Mass General Hospital and Harvard Medical School , Boston , MA , USA.

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.

Methods: In a community-based setting, we surveyed 40 women with or at risk for HIV about factors which might facilitate or impede engagement in CVD research. Read More

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http://dx.doi.org/10.1080/15284336.2017.1297551DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5607953PMC
March 2017
11 Reads

Feasibility of identifying out of care HIV-positive patients in a hospital setting and enrolling them in a retention intervention.

HIV Clin Trials 2017 03 17;18(2):75-82. Epub 2017 Feb 17.

a VA Health Services Research Center of Excellence, Michael E. DeBakey Veterans Affairs Medical Center , Houston , TX , USA.

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. Read More

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http://dx.doi.org/10.1080/15284336.2017.1287536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5611820PMC
March 2017
19 Reads
1 Citation
2.141 Impact Factor