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HIV clinical trials

Sara Lodi, Shweta Sharma, Jens D Lundgren, Andrew N Phillips, Stephen R Cole, Roger Logan, Brian K Agan, Abdel Babiker, Hartwig Klinker, Haitao Chu, Matthew Law, James D Neaton, Miguel A Hernán
OBJECTIVE: The Strategic Timing of AntiRetroviral Treatment (START) trial found a lower risk of a composite clinical outcome in HIV-positive individuals assigned to immediate initiation of antiretroviral therapy (ART) compared with those assigned to deferred initiation. However, 30% of those assigned to deferred initiation started ART earlier than the protocol specified. To supplement the published intention-to-treat (ITT) effect estimates, here we estimate the per-protocol effect of immediate versus deferred ART initiation in START...
November 13, 2016: AIDS
Andrew F Auld, Tefera Agizew, Sherri Pals, Alyssa Finlay, Ndwapi Ndwapi, Rosanna Boyd, Heather Alexander, Anikie Mathoma, Joyce Basotli, Sambayawo Gwebe-Nyirenda, James Shepherd, Tedd V Ellerbrock, Anand Date
BACKGROUND: In 2012, as a pilot for Botswana's national Xpert MTB/RIF (Xpert) rollout plans, intensified tuberculosis (TB) case finding (ICF) activities were strengthened at 22 HIV treatment clinics prior to phased activation of 13 Xpert instruments. Together, the strengthened ICF intervention and Xpert activation are referred to as the "Xpert package". METHODS: The evaluation, called the Xpert Package Rollout Evaluation using a Stepped-wedge design (XPRES), has two key objectives: (1) to compare sensitivity of microscopy-based and Xpert-based pulmonary TB diagnostic algorithms in diagnosing sputum culture-positive TB; and (2) to evaluate impact of the "Xpert package" on all-cause, 6-month, adult antiretroviral therapy (ART) mortality...
October 26, 2016: BMC Infectious Diseases
Deirdre Sawinski
HIV+ patients are at increased risk for end-stage renal disease, but HIV infection was once considered a contraindication to renal transplantation. However, contemporary studies from the United States and Europe have now demonstrated that renal transplantation is a safe and effective treatment for end-stage renal disease in HIV patients, with equivalent patient and allograft survival to those uninfected. Broader experience in transplantation in HIV+ patients has identified unique challenges including high rates of acute rejection, delayed graft function, and significant drug-drug interactions...
October 11, 2016: Transplantation Reviews
Karen L Dugosh, David S Festinger, Jessica L Lipkin
Drug courts address issues such as employment and housing but largely miss the opportunity to address important health care issues. The current study examined the prevalence and correlates of chronic medical conditions among a sample of drug court clients who were participating in a clinical trial of an intervention to reduce HIV risk. A total of 256 clients completed a health survey at entry into the drug court program and 9 months post-entry. The baseline health survey included a comprehensive list of chronic medical conditions, and participants were asked to indicate which, if any, they had ever been diagnosed as having...
December 2016: Journal of Substance Abuse Treatment
Guillaume Andrieu, Anna C Belkina, Gerald V Denis
Several cancer clinical trials for small molecule inhibitors of BET bromodomain proteins have been initiated. There is enthusiasm for the anti-proliferative effect of inhibiting BRD4, one of the targets of these inhibitors, which is thought to cooperate with MYC, a long-desired target for cancer therapeutics. However, no current inhibitor is selective for BRD4 among the three somatic BET proteins, which include BRD2 and BRD3; their respective functions are partially overlapping and none are functionally redundant with BRD4...
March 2016: Drug Discovery Today. Technologies
Kathryn Schnippel, Rebecca H Berhanu, Andrew Black, Cynthia Firnhaber, Norah Maitisa, Denise Evans, Edina Sinanovic
BACKGROUND: According to the World Health Organization, South Africa ranks as one of the highest burden of TB, TB/HIV co-infection, and drug-resistant TB (DR-TB) countries. DR-TB treatment is complicated to administer and relies on the use of multiple toxic drugs, with potential for severe adverse drug reactions. We report the occurrence of adverse events (AEs) during a standardised DR-TB treatment regimen at two outpatient, decentralized, public-sector sites in Johannesburg, South Africa...
October 21, 2016: BMC Infectious Diseases
Manan Jhaveri, Nicholas Procaccini, Kris V Kowdley
Chronic Hepatitis C is a major public health problem. The chronicity of the Hepatitis C can lead to advanced liver disease, cirrhosis and even hepatocellular carcinoma. Chronic hepatitis C is the leading indication of for liver transplantation in the United States. Since the introduction of directly acting antiviral agents (DAAs), there have been there have been dramatic advances in treatment of hepatitis C in terms of tolerability, duration of therapy with significant increases in the rates of sustained virology response (SVR)...
October 21, 2016: Minerva Gastroenterologica e Dietologica
Dale Barnhart, Ellen Hertzmark, Enju Liu, Ester Mungure, Aisa N Muya, David Sando, Guerino Chalamilla, Nzovu Ulenga, Till Bärnighausen, Wafaie Fawzi, Donna Spiegelman
INTRODUCTION: Researchers planning cluster-randomized controlled trials (cRCTs) require estimates of the intra-cluster correlation coefficient (ICC) from previous studies for sample size calculations. This paper fills a persistent gap in the literature by providing estimates of ICCs for many key HIV-related clinical outcomes. METHODS: Data from HIV-positive patients from 47 HIV care and treatment clinics in Dar es Salaam, Tanzania were used to calculate ICCs by site of enrollment or site of ART initiation for various clinical outcomes using cross-sectional and longitudinal data...
December 15, 2016: Contemporary Clinical Trials Communications
Aditya H Gaur, Hilda Kizito, Wasana Prasitsueubsai, Natella Rakhmanina, Mohammed Rassool, Rana Chakraborty, Jagmohan Batra, Pope Kosalaraksa, Wicharn Luesomboon, Danielle Porter, Yongwu Shao, Michael Myers, Lillian Ting, Devi SenGupta, Erin Quirk, Martin S Rhee
BACKGROUND: The prodrug tenofovir alafenamide is associated with improved renal and bone safety compared with tenofovir disoproxil fumarate. We aimed to assess safety, pharmacokinetics, and efficacy of this single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-infected, treatment-naive adolescents. METHODS: We did a 48 week, single-arm, open-label trial in treatment-naive adolescents with HIV from ten hospital clinics in South Africa, Thailand, Uganda, and the USA...
October 17, 2016: Lancet HIV
Rafael E Pedro, Débora A Guariglia, Sidney B Peres, Solange M Moraes
BACKGROUND: Human immunodeficiency virus-associated lipodystrophy syndrome (HALS) is a major problem among people living with HIV/aids. The exercise training has been used for its treatment; however, the knowledge about benefits and safety still is emerging. The aim was systematically review the literature for physiological, metabolic, immunologic, and morphologic adaptations to aerobic, resistance, and concurrent training in people living with HALS. METHODS: A search of the Medline, Embase, Cinahl, Lilacs, Scielo, Web of Science, the Cochrane Controlled Trials Register Library and PEDro was performed...
October 20, 2016: Journal of Sports Medicine and Physical Fitness
Denise Dion Hallfors, Bonita J Iritani, Lei Zhang, Shane Hartman, Winnie K Luseno, Elias Mpofu, Simbarashe Rusakaniko
This study examines the association between religious affiliation and reasons for marriage, perceived church attitudes, and reproductive health-seeking behaviors, including HIV testing, among young women in eastern rural Zimbabwe. The sample comprised women (N = 35) who had married by 2012 while participating in a larger randomized controlled trial (RCT) to test the effects of school support on HIV-related risk. The RCT sample was identified in 2007 as all female sixth graders in 25 rural eastern Zimbabwe primary schools whose parents, one or both, had died (N = 328)...
December 2016: SAHARA J: Journal of Social Aspects of HIV/AIDS Research Alliance
Iryna Zablotska, Andrew E Grulich, Nittaya Phanuphak, Tarandeep Anand, Surang Janyam, Midnight Poonkasetwattana, Rachel Baggaley, Frits van Griensven, Ying-Ru Lo
INTRODUCTION: HIV epidemics in the Asia-Pacific region are concentrated among men who have sex with men (MSM) and other key populations. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention and could be a potential game changer in the region. We discuss the progress towards PrEP implementation in the Asia-Pacific region, including opportunities and barriers. DISCUSSION: Awareness about PrEP in the Asia-Pacific is still low and so are its levels of use...
2016: Journal of the International AIDS Society
Jae M Sevelius, Madeline B Deutsch, Robert Grant
INTRODUCTION: Globally, transgender ("trans") women are one of the key populations most disproportionately impacted by HIV. Pre-exposure prophylaxis (PrEP) is the newest and most promising biomedical HIV prevention intervention to date. This paper reviews relevant literature to describe the current state of the science and describes the potential role of PrEP among trans women, including a discussion of unique considerations for maximizing the impact of PrEP for this vulnerable population...
2016: Journal of the International AIDS Society
Sheena Mary McCormack, Veronica Noseda, Jean-Michel Molina
INTRODUCTION: In contrast to the global trend showing a decline in new HIV infections, the number reported in the World Health Organization (WHO) region of Europe is increasing. Health systems are disparate, but even countries with free access to screening and treatment observe continuing high rates of new infections in key populations, notably men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) is only available in France. This commentary describes the European epidemics and healthcare settings where PrEP could be delivered, how need might be estimated for MSM and the residual barriers to access...
2016: Journal of the International AIDS Society
Héloïse M Delagrèverie, Constance Delaugerre, Sharon R Lewin, Steven G Deeks, Jonathan Z Li
In chronic human immunodeficiency virus (HIV)-1 infection, long-lived latently infected cells are the major barrier to virus eradication and functional cure. Several therapeutic strategies to perturb, eliminate, and/or control this reservoir are now being pursued in the clinic. These strategies include latency reversal agents (LRAs) designed to reactivate HIV-1 ribonucleic acid transcription and virus production and a variety of immune-modifying drugs designed to reverse latency, block homeostatic proliferation, and replenish the viral reservoir, eliminate virus-producing cells, and/or control HIV replication after cessation of antiretroviral therapy...
October 2016: Open Forum Infectious Diseases
Xuesong Han, Ahmedin Jemal, Erin Hulland, Edgar P Simard, Loretta Nastoupil, Elizabeth M Ward, Christopher R Flowers
BACKGROUND: Highly active antiretroviral therapy (HAART) has extended the life expectancy of HIV/AIDS patients to approach that of the general population. However, it remains unclear whether HIV infection affects the survival of lymphoma patients in the HAART era. METHODS: Patients diagnosed with Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), peripheral T-cell lymphoma (PTCL) or follicular lymphoma (FL) during 2004-2011 were identified from the National Cancer Database...
October 18, 2016: Cancer Epidemiology, Biomarkers & Prevention
Nicolás Merchante, Sofía Ibarra, Boris Revollo, Francisco Rodríguez-Arrondo, Esperanza Merino, Marcial Delgado-Fernández, Marta Montero-Alonso, Francisco Téllez, Maria J Galindo, Antonio Rivero-Juárez, Maria A García, Carlos Mínguez, Alberto Romero-Palacios, Miguel Del Toro, Juan A Pineda
OBJECTIVE: To report the real-life results of sorafenib use in a cohort of HIV-infected patients with hepatocellular carcinoma (HCC). METHODS: The GEHEP-002 cohort ( ID: NCT02785835) has recruited 302 HCC cases diagnosed in HIV-infected patients from 32 centers from Spain. RIS-HEP12 study included 44 (14%) cases that have received at least one dose of sorafenib. The overall survival after the start of treatment (OSaT) was the main efficacy outcome...
October 14, 2016: AIDS
Kristi E Gamarel, Larry Brown, Christopher W Kahler, M Isabel Fernandez, Douglas Bruce, Sharon Nichols
OBJECTIVES: The purpose of this study was to better understand the prevalence and correlates of substance use behaviors among HIV-infected adolescents in HIV care settings. METHODS: A cross-sectional sample of 2216 youth living with HIV (YLWH; ages 12-26) were recruited through the Adolescent Trials Network for HIV Interventions. Participants completed a one-time survey on sociodemographic factors, substance use and health behaviors. We used logistic regression models to understand the correlates of substance use outcomes...
October 11, 2016: Drug and Alcohol Dependence
Bingjie Shi, Juan Li, Xuanling Shi, Wenxu Jia, Yi Wen, Xiongbing Hu, Fengfeng Zhuang, Jianzhong Xi, Linqi Zhang
Transcription activator-like effector nuclease (TALEN) represents a valuable tool for genomic engineering due to its single-nucleotide precision, high nuclease activity and low cytotoxicity. We report here systematic design and characterization of twenty eight novel TALENs targeting multiple regions of CCR5 gene (CCR5-TALEN) which encodes the co-receptor critical for entry of human immunodeficiency virus type I (HIV-1). By systemic characterization of these CCR5-TALENs, we have identified one (CCR5-TALEN-515) with higher nuclease activity, specificity and lower cytotoxicity compared to zinc-finger nuclease (CCR5-ZFN) currently undergoing clinical trials...
October 3, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Christopher E Jones, Áine McKnight
PURPOSE OF REVIEW: The present review will discuss recent advances in the development of anti-HIV therapies inspired by studies of the mechanisms of host restriction factor-mediated resistance to HIV infection. RECENT FINDINGS: Manipulating the interplay between host cell restriction factors and viral accessory factors that overcome them can potentially be therapeutically useful. Preliminarily successful therapies - some of which are entering clinical trials - either inhibit the ability of virus to evade restriction factor-mediated immunity, or promote intracellular levels of restriction factors...
October 5, 2016: Current Opinion in Infectious Diseases
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