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HIV clinical trials

Felicia C Chow, Michael R Wilson, Kunling Wu, Ronald J Ellis, Ronald J Bosch, Benjamin P Linas
OBJECTIVE: To investigate the incidence of first-ever stroke/transient ischemic attack (TIA) and associated risk factors in a cohort of persons living with HIV infection (PLWH). DESIGN: Observational cohort study METHODS:: We determined incidence rates of first-ever stroke/TIA in PLWH after ART initiation from the AIDS Clinical Trials Group ALLRT cohort and its parent trials. Poisson regression models evaluated baseline and time-varying covariates as risk factors for stroke/TIA...
March 15, 2018: AIDS
Noemia Teixeira de Siqueira-Filha, Maria de Fatima Militao de Albuquerque, Laura Cunha Rodrigues, Rosa Legood, Andreia Costa Santos
OBJECTIVE: The objective of this study was to measure the costs of people living with HIV (PLHIV) as well as active tuberculosis (TB/HIV), latent tuberculosis infection (LTBI/HIV) or without TB (HIV/AIDS). METHODS: We analysed the costs through the entire pathway of care during the prediagnosis and treatment periods from the Brazilian public health system perspective. We applied a combination of bottom-up and top-down approaches to capture and estimate direct medical and non-medical costs...
March 15, 2018: Sexually Transmitted Infections
Dean G Cruess, Kaylee E Burnham, David J Finitsis, Brett M Goshe, Lauren Strainge, Moira Kalichman, Tamar Grebler, Chauncey Cherry, Seth C Kalichman
Background: HIV disproportionately affects sexual minority men, and developing strategies to reduce transmission risk is a public health priority. Purpose: The goal was to empirically test a newly developed, Information, Motivation, Behavioral skills (IMB) theoretically derived, online HIV sexual risk reduction intervention (called HINTS) among a sample of sexual minority men living with HIV. Methods: Participants were 167 men randomized to either the four-session online HINTS intervention or to a time-matched, online control condition...
February 5, 2018: Annals of Behavioral Medicine: a Publication of the Society of Behavioral Medicine
Joy Y Feng
Nucleoside and nucleotide analogs have played significant roles in antiviral therapies and are valued for their impressive potency and high barrier to resistance. They have been approved for treatment of herpes simplex virus-1, HIV, HBV, HCV, and influenza, and new drugs are being developed for the treatment of RSV, Ebola, coronavirus MERS, and other emerging viruses. However, this class of compounds has also experienced a high attrition rate in clinical trials due to toxicity. In this review, we discuss the utility of different biochemical and cell-based assays and provide recommendations for assessing toxicity liability before entering animal toxicity studies...
January 2018: Antiviral Chemistry & Chemotherapy
Richard A Crosby, Leandro Mena, Rachel Vickers Smith
The aim of this study is to determine, among young Black men who have sex with men (YBMSM), the 12-month efficacy of a single-session, clinic-based intervention promoting condom use to enhance sexual pleasure (purpose 1) and the use of condoms from the start-to-finish of anal sex (purpose 2). A pre-test, post-test randomized controlled trial was conducted, using a 12-month period of follow-up observation, in STI clinics. Data from 394 YBMSM completing baseline and 12-month follow-up assessments were analyzed...
March 9, 2018: Health Education Research
N T de Siqueira Filha, M de Fatima Pessoa Militao de Albuquerque, R Legood, L Rodrigues, A C Santos
OBJECTIVE: The objective of this study was to evaluate the direct and indirect costs of tuberculosis (TB) (active and latent TB [LTB]) and HIV co-infection from the patient perspective. STUDY DESIGN: Costing study conducted alongside a pragmatic clinical trial. METHODS: The study was conducted in Brazil in a referral service for HIV/AIDS. We applied a standardised questionnaire to collect data about out-of-pocket expenses and indirect cost...
March 10, 2018: Public Health
Theodoros Kelesidis, Carlee B Moser, Elizabeth Johnston, James H Stein, Michael P Dube, Otto O Yang, Grace A McComsey, Judith S Currier, Todd T Brown
BACKGROUND: The contributions of the Receptor activator of nuclear factor kappa-B ligand (RANKL)/osteoprotegerin (OPG) axis to cardiovascular and bone disease in treated HIV-1 infection is not well-defined. SETTING: Prospective, observational, longitudinal study. METHODS: In a subset analysis of a prospective randomized clinical trial, 234 HIV-1-infected antiretroviral therapy (ART)-naïve participants received tenofovir-emtricitabine plus either atazanavir/ritonavir, darunavir/ritonavir, or raltegravir and achieved plasma HIV-1 RNA <50 copies/ml by week 24 and thereafter...
March 12, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
William E Cunningham, Robert E Weiss, Terry Nakazono, Mark A Malek, Steve J Shoptaw, Susan L Ettner, Nina T Harawa
Importance: Diagnosis of human immunodeficiency virus (HIV) infection, linkage and retention in care, and adherence to antiretroviral therapy are steps in the care continuum enabling consistent viral suppression for people living with HIV, extending longevity and preventing further transmission. While incarcerated, people living with HIV receive antiretroviral therapy and achieve viral suppression more consistently than after they are released. No interventions have shown sustained viral suppression after jail release...
March 12, 2018: JAMA Internal Medicine
Daniel Enosi Tuipulotu, Natalie E Netzler, Jennifer H Lun, Jason M Mackenzie, Peter A White
Norovirus infections are a significant health and economic burden globally, accounting for hundreds of millions of cases of acute gastroenteritis every year. In the absence of an approved norovirus vaccine, there is an urgent need to develop antivirals to treat chronic infections, and provide prophylactic therapy to limit viral spread during epidemics and pandemics. Toll-like receptor (TLR) agonists have been explored widely for their antiviral potential and several are progressing through clinical trials for the treatment of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and as adjuvants for norovirus virus-like particle (VLP) vaccines...
March 12, 2018: Antimicrobial Agents and Chemotherapy
Patrick O'Byrne, Paul MacPherson, Lauren Orser
We trialed a nurse-led HIV postexposure prophylaxis (PEP) program in two sexually transmitted infection clinics in Ottawa, Canada. From September 5, 2013 to September 4, 2015, 112 persons sought PEP: 103 were male, of whom 84 were men who have sex with men (MSM). Seventy-two patients (59 MSM) initiated PEP; 11 were diagnosed with HIV: 6 diagnoses occurred during initial assessment (all MSM; 1 also shared injection equipment); 5 MSM were diagnosed with HIV within 1 year of seeking PEP. This level of positivity indicated that, when access is facilitated, individuals at high risk of HIV seek PEP...
February 17, 2018: Journal of the Association of Nurses in AIDS Care: JANAC
Monica Gandhi, Rajesh T Gandhi, Andrei Stefanescu, Ronald J Bosch, Joshua C Cyktor, Howard Horng, Alexander Louie, Nhi Phung, Joseph J Eron, Evelyn Hogg, Bernard J C Macatangay, Christopher Hensel, Courtney V Fletcher, John W Mellors, Deborah K McMahon
Data on the relationship of antiretroviral exposure to measures of human immunodeficiency virus (HIV) persistence are limited. To address this gap, multiple viral, immunologic, and pharmacologic measures were analyzed from individuals with sustained virologic suppression on therapy (median 7 years) in the AIDS Clinical Trials Group A5321 cohort. Among 110 participants on tenofovir-(TFV)-disoproxil-fumarate (TDF)/emtricitabine (FTC)-containing regimens, we found no significant correlation between hair concentrations of individual antiretrovirals (ARVs) in the regimen and measures of HIV persistence (plasma HIV-1 RNA by single copy assay, cell-associated-DNA, cell-associated RNA) or soluble markers of inflammation...
February 26, 2018: Journal of Infectious Diseases
Ahizechukwu C Eke, Nahida Chakhtoura, Angela Kashuba, Brookie M Best, Craig Sykes, Jiajia Wang, Alice M Stek, Elizabeth Smith, Samantha Calabrese, Edmund V Capparelli, Mark Mirochnick
BACKGROUND: Concentrations of antiretrovirals (ARVs) in the genital tract play a key role in pre-exposure prophylaxis. This study aims to describe rilpivirine (Edurant) concentrations in the genital tract in pregnant and postpartum women. METHODS: International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1026s is an ongoing, prospective study of antiretroviral pharmacokinetics (PK) in HIV infected pregnant women that include a cohort receiving rilpivirine combination regimen...
March 8, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Muge Cevik, Chloe Orkin
PURPOSE OF REVIEW: In an era when virological efficacy approaches 100%, novel antiretroviral (ARV) therapies must deliver better tolerability, safety, and convenient coformulated regimens. We review the phase II and III clinical data on the fixed dose combination (FDC) darunavir (DRV) 800mg / cobicistat (COBI/C) 150 mg / emtricitabine (F/FTC) 200 mg / tenofovir alafenamide fumarate (TAF) 10mg (D/C/F/TAF) for the treatment of HIV-1 infection. RECENT FINDINGS: In an exploratory phase II study, D/C/F/TAF FDC demonstrated similar virological efficacy to darunavir/cobicistat FDC + F /tenofovir disoproxil fumarate (TDF) FDC in treatment-naive HIV-1-infected individuals with favorable bone and renal outcomes...
March 9, 2018: Current Opinion in HIV and AIDS
Jane Goudge, Tobias Chirwa, Sandra Eldridge, Francesc Xavier F Gómez-Olivé, Chodziwadziwa Kabudula, Felix Limbani, Eustasius Musenge, Margaret Thorogood
Introduction: In low/middle-income countries with substantial HIV and tuberculosis epidemics, health services often neglect other highly prevalent chronic conditions, such as hypertension, which as a result are poorly managed. This paper reports on a study to assess the effect on hypertension management of lay health workers (LHW) working in South African rural primary healthcare clinics to support the provision of integrated chronic care. Methods: A pragmatic cluster randomised trial with a process evaluation in eight rural clinics assessed the effect of adding two LHWs supporting nurses in providing chronic disease care in each intervention clinic over 18 months...
2018: BMJ Global Health
Justin C Graves, Peter Elyanu, Christine J Schellack, Barbara Asire, Margaret L Prust, Marta R Prescott, Esther Mirembe, Ivan Lukabwe, Betty Mirembe, Joshua Musinguzi, Sarah A Moberley
BACKGROUND: In 2013, Uganda adopted a test-and-treat policy for HIV patients 15 years or younger. Low retention rates among paediatric and adolescent antiretroviral therapy (ART) initiates could severely limit the impact of this new policy. This evaluation tested the impact of a differentiated care model called Family Clinic Day (FCD), a family-centered appointment scheduling and health education intervention on patient retention and adherence to monthly appointment scheduling. METHODS: We conducted a cluster randomized controlled trial, from October 2014 to March 2015...
2018: PloS One
Ann J Hessell, Mariya B Shapiro, Rebecca Powell, Delphine C Malherbe, Sean P McBurney, Shilpi Pandey, Tracy Cheever, William F Sutton, Christoph Kahl, Byung Park, Susan Zolla-Pazner, Nancy L Haigwood
A high level of V1V2-specific IgG antibodies in vaccinees' sera was the only independent variable that correlated with a reduced risk of HIV acquisition in the RV144 clinical trial. In contrast, IgG avidity, antibody neutralization, and antibody-dependent cellular cytotoxicity each failed as independent correlates of infection. Extended analyses of RV144 samples demonstrated antiviral activity of V1V2-specific vaccine-induced antibodies. V2-specific antibodies have also been associated with protection from SIV, and the V2i-specific subset of human monoclonal antibodies (mAbs), while poor neutralizers, mediate Fc-dependent antiviral functions in vitro The objective of this study was to determine the protective efficacy of a V2i-specific human mAb 830A against mucosal SHIV challenge...
March 7, 2018: Journal of Virology
Abraham Siika, Leanne McCabe, Mutsa Bwakura-Dangarembizi, Cissy Kityo, Jane Mallewa, Jay Berkley, Kath Maitland, Anna Griffiths, Keith Baleeta, Shepherd Mudzingwa, James Abach, Kusum Nathoo, Margaret J Thomason, Andrew J Prendergast, Ann Sarah Walker, Diana M Gibb
Background: Severely immunocompromised human immunodeficiency virus (HIV)-infected individuals have high mortality shortly after starting antiretroviral therapy (ART). We investigated predictors of early mortality and "late presenter" phenotypes. Methods: The Reduction of EArly MortaLITY (REALITY) trial enrolled ART-naive adults and children ≥5 years of age with CD4 counts <100 cells/µL initiating ART in Uganda, Zimbabwe, Malawi, and Kenya. Baseline predictors of mortality through 48 weeks were identified using Cox regression with backwards elimination (exit P > ...
March 4, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Christoph Höner Zu Siederdissen, Peter Buggisch, Klaus Böker, Eckart Schott, Hartwig Klinker, Anita Pathil, Heike Pfeiffer-Vornkahl, Thomas Berg, Christoph Sarrazin, Dietrich Hüppe, Michael P Manns, Stefan Mauss
Background: In pivotal studies with direct-acting antivirals (DAAs), rates of sustained virological response in hepatitis C genotype 1 infection are >90%. Objective: The objective of this article is to assess real-world safety and effectiveness of DAA treatment in a prospective multicenter registry study. Methods: The German Hepatitis C-Registry includes 6606 patients with genotype 1 from 246 centers, treated between February 2014 and June 2016 at the discretion of the physician...
March 2018: United European Gastroenterology Journal
Niklaus D Labhardt, Isaac Ringera, Thabo I Lejone, Thomas Klimkait, Josephine Muhairwe, Alain Amstutz, Tracy R Glass
Importance: Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART). Objective: To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa. Design, Setting, and Participants: Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho...
March 6, 2018: JAMA: the Journal of the American Medical Association
Elizabeth Nalintya, David B Meya, Sarah Lofgren, Kathy Huppler Hullsiek, David R Boulware, Radha Rajasingham
BACKGROUND: Cryptococcus is a leading cause of AIDS-related mortality. Cryptococcal antigen (CrAg) is detectable in blood before meningitis onset, and predicts death. CrAg screening amongst those with advanced HIV, and treatment of those CrAg+ with fluconazole has demonstrated survival benefit. However, implementation and widespread uptake have been slow outside of clinical trials. METHODS: We designed a CrAg screening program for routine care that incorporated intensive education and training of clinic staff...
March 2, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
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