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HIV clinical trials

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https://www.readbyqxmd.com/read/28742880/same-day-hiv-testing-with-initiation-of-antiretroviral-therapy-versus-standard-care-for-persons-living-with-hiv-a-randomized-unblinded-trial
#1
Serena P Koenig, Nancy Dorvil, Jessy G Dévieux, Bethany L Hedt-Gauthier, Cynthia Riviere, Mikerlyne Faustin, Kerlyne Lavoile, Christian Perodin, Alexandra Apollon, Limathe Duverger, Margaret L McNairy, Kelly A Hennessey, Ariadne Souroutzidis, Pierre-Yves Cremieux, Patrice Severe, Jean W Pape
BACKGROUND: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression. METHODS AND FINDINGS: We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3...
July 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28742529/risk-factors-for-early-mortality-on-antiretroviral-therapy-in-advanced-hiv-infected-adults
#2
Gregory P Bisson, Ritesh Ramchandani, Sachiko Miyahara, Rosie Mngqibisa, Mitch Matoga, McNeil Ngongondo, Wadzanai Samaneka, Lucy Koech, Kogieleum Naidoo, Mohammed Rassool, Fredrick Kirui, Peter Banda, Vidya Mave, Dileep Kadam, Paul Leger, German Henostroza, Yukari C Manabe, Jing Bao, Johnstone Kumwenda, Amita Gupta, Mina C Hosseinipour
BACKGROUND: Many HIV-infected individuals present with advanced HIV disease. These patients are at high risk of death after antiretroviral therapy (ART) initiation, but risk factors for death in these patients are unclear. METHODS: We used data from a multi-site randomized trial comparing empiric versus preventive TB therapy in HIV-infected adults initiating ART with CD4 counts <50 cells/mm to evaluate risk factors for death within 48 weeks after ART initiation...
July 24, 2017: AIDS
https://www.readbyqxmd.com/read/28741134/a-cluster-randomised-trial-to-determine-the-efficacy-of-the-feeding-buddies-programme-in-improving-exclusive-breastfeeding-rates-among-hiv-infected-women-in-rural-kwazulu-natal-south-africa
#3
Penelope Reimers, Kiersten Israel-Ballard, Marlies Craig, Lenore Spies, Ibou Thior, Frank Tanser, Anna Coutsoudis
This cluster randomised trial in KwaZulu-Natal South Africa, evaluated the implementation of a Feeding Buddies (FB) programme to improve exclusive breastfeeding (EBF) amongst human immunodeficiency virus infected mothers. Eight clinics were randomly allocated to intervention and control arms respectively. Pregnant women attending the prevention of mother-to-child transmission program and intending to EBF were enrolled: control (n = 326), intervention (n = 299). Intervention mothers selected FBs to support them and they were trained together (four sessions)...
July 24, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28740692/durable-complete-response-to-nivolumab-in-a-patient-with-hiv-and-metastatic-non-small-cell-lung-cancer
#4
Brennan McCullar, Taylor Alloway, Michael Martin
Programmed death 1 (PD-1) inhibitors have been shown to increase overall survival in non-small cell lung cancer (NSCLC) patients. HIV patients have increased expression of PD-1 on their T-cell surfaces. We describe a patient with well-controlled HIV and NSCLC who underwent treatment with nivolumab and had a durable complete response (CR) with his viral load remaining undetectable. To date there is only one case report of a cancer patient with melanoma and with HIV treated with a programmed death ligand 1 (PD-L1) inhibitor...
June 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28738857/investigating-interventions-to-increase-uptake-of-hiv-testing-and-linkage-into-care-or-prevention-for-male-partners-of-pregnant-women-in-antenatal-clinics-in-blantyre-malawi-study-protocol-for-a-cluster-randomised-trial
#5
Augustine T Choko, Katherine Fielding, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Nicola Desmond, Moses K Kumwenda, Elizabeth L Corbett
BACKGROUND: Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women...
July 24, 2017: Trials
https://www.readbyqxmd.com/read/28738768/current-status-of-the-pharmacokinetics-and-pharmacodynamics-of-hiv-1-entry-inhibitors-and-hiv-therapy
#6
Fengyan Xu, Edward P Acosta, Liyu Liang, Yingchun He, Juan Yang, Corenna Kerstner-Wood, Qingshang Zheng, Jihan Huang, Kun Wang
Human immunodeficiency virus (HIV) entry inhibitors target the first step of the HIV life cycle and efficiently inhibit HIV from infecting the immune cells which is a key prerequisite for viral spread. Because of their unique mechanism of action on cell-cell transmission they may provide a promising perspective for the treatment of AIDS. Maraviroc (MVC) and Enfuvirtide (ENF) have been approved by the FDA for the treatment of HIV-1 infection. Attachment inhibitors (BMS-663068 and TNX-355) and co-receptor inhibitors (PRO-140 and Cenicriviroc (CVC)) have reached phase II or III clinical trials...
July 24, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28737291/nucleoside-reverse-transcriptase-inhibitor-reducing-strategies-in-hiv-treatment-assessing-the-evidence
#7
REVIEW
C Orkin, J M Llibre, S Gallien, A Antinori, Gmn Behrens, A Carr
Antiretroviral (ARV) therapy, comprising a backbone of two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus another ARV, is the recognized standard of care (SOC), which has helped extend life expectancy in people living with HIV. In a quest to reduce lifelong drug exposure and minimize or avoid the toxicity of NRTIs, "NRTI-reducing" regimens have been investigated. This descriptive review assessing the results of NRTI-reducing strategies from the largest randomized trials focuses on virological efficacy, resistance, regimen safety (in terms of bone mineral density, renal function, lipids and central nervous system function) and simplicity...
July 24, 2017: HIV Medicine
https://www.readbyqxmd.com/read/28736763/immunologic-effects-of-maraviroc-in-hiv-infected-patients-with-severe-cd4-lymphopenia-starting-antiretroviral-therapy-a-sub-study-of-the-cadiris-trial
#8
Pablo F Belaunzarán-Zamudio, Livio Azzoni, David H Canaday, Yanink N Caro-Vega, Brian Clagget, Mohammed S Rassool, Benigno Rodriguez, Ian Sanne, Irini Sereti, Juan G Sierra-Madero, Michael M Lederman
BACKGROUND: We aimed to describe the mechanisms of immunological recovery and the effects of blocking CCR5 in patients starting ART with advanced HIV-infection. METHODS: This was a sub-study of a 48 week double-blind, clinical trial where patients starting ART with CD4+ cell counts <100 cells/uL were randomized to receive maraviroc or a placebo. CD4+ and CD8+ cell maturation phenotypes, expression of PD-1 and CCR5, and activation indices were measured at weeks 0, 4, 12, 24, and 48...
2017: Pathogens & Immunity
https://www.readbyqxmd.com/read/28733854/process-evaluation-of-a-clinical-trial-to-test-school-support-as-hiv-prevention-among-orphaned-adolescents-in-western-kenya
#9
Denise Dion Hallfors, Hyunsan Cho, Shane Hartman, Isabella Mbai, Carolyne Atieno Ouma, Carolyn Tucker Halpern
Orphaned adolescents are a large and vulnerable population in sub-Saharan Africa, at higher risk for HIV than non-orphans. Yet prevention of new infection is critical for adolescents since they are less likely than adults to enter and remain in treatment and are the only age group with rising AIDS death rates. We report process evaluation for a randomized controlled trial (RCT) testing support to stay in school (tuition, uniform, nurse visits) as an HIV prevention strategy for orphaned Kenyan adolescents. The RCT found no intervention effect on HIV/HSV-2 biomarker outcomes...
July 21, 2017: Prevention Science: the Official Journal of the Society for Prevention Research
https://www.readbyqxmd.com/read/28733564/the-clinical-features-and-treatment-outcome-of-chronic-hepatitis-c-with-pegylated-interferon-and-ribavirin-in-routine-care
#10
S S Tan, Z Adlin Nadia
AIM: To describe the clinical characteristic of hepatitis C (HCV) patients and the results of pegylated interferon and ribavirin (PegIFN/RBV) therapy in a routine clinical practice. METHODS: A retrospective review of consecutive HCV patients treated with PegIFN/RBV in 2004 to 2012. RESULTS: A total of 273 patients received treatment. The mean age was 44.16 ± 10.5 years and 76% were male. The top 2 self-reported risks were blood or blood product transfusion before 1994 and injection drug use, found in 57...
June 2017: Medical Journal of Malaysia
https://www.readbyqxmd.com/read/28729879/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#11
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28729158/fixed-dose-combination-dolutegravir-abacavir-and-lamivudine-versus-ritonavir-boosted-atazanavir-plus-tenofovir-disoproxil-fumarate-and-emtricitabine-in-previously-untreated-women-with-hiv-1-infection-aria-week-48-results-from-a-randomised-open-label-non-inferiority
#12
Catherine Orrell, Debbie P Hagins, Elena Belonosova, Norma Porteiro, Sharon Walmsley, Vicenç Falcó, Choy Y Man, Alicia Aylott, Ann M Buchanan, Brian Wynne, Cindy Vavro, Michael Aboud, Kimberly Y Smith
BACKGROUND: Dolutegravir is a once-daily integrase strand transfer inhibitor with no need for pharmacokinetic boosting that is approved for the treatment of HIV-1 infection. Because women are often under-represented in HIV clinical trials, we addressed the safety and efficacy of dolutegravir in women with HIV-1. METHODS: The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-group, non-inferiority phase 3b study done in 86 hospital and university infectious disease clinics, local health clinics, and private infectious disease clinics in 12 countries and one US territory, in North America, South America, Europe, Africa, and Asia...
July 17, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28728927/hcv-infected-and-hiv-hcv-co-infected-individuals-treated-with-direct-acting-antivirals-to-what-extent-do-they-differ
#13
Giuseppe Bruno, Annalisa Saracino, Luigia Scudeller, Claudia Fabrizio, Raffaele Dell'Acqua, Eugenio Milano, Michele Milella, Nicoletta Ladisa, Laura Monno, Gioacchino Angarano
BACKGROUND AND AIMS: DAA-based anti-HCV treatment has been associated with high rates of sustained virological response (SVR) and good tolerability in clinical randomized trials. To assess safety and effectiveness of DAAs in both HCV mono-infected and HIV/HCV co-infected patients. METHODS: All consecutive HCV-infected patients, including HIV/HCV co-infected, receiving DAA-based treatment from February 2015 until September 2016 in our Clinic, were included. Clinical, virological and biochemical data were retrieved...
July 17, 2017: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28727491/impact-of-point-of-care-xpert-mtb-rif-on-tuberculosis-treatment-initiation-a-cluster-randomised-trial
#14
Richard J Lessells, Graham S Cooke, Nuala McGrath, Mark P Nicol, Marie-Louise Newell, Peter Godfrey-Faussett
RATIONALE: Point-of-care (POC) diagnostics have potential to reduce pre-treatment loss to follow-up and delays to initiation of appropriate TB treatment. OBJECTIVE: To evaluate the effect of a POC diagnostic strategy on initiation of appropriate TB treatment. METHODS: A cluster randomised trial of adults with cough who were HIV positive and/or at high risk of drug-resistant TB. Two-week time blocks were randomised to two strategies (i) Xpert performed at district hospital laboratory (ii) POC Xpert performed at primary health care clinic...
July 20, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28720147/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#15
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
July 18, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28720039/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
#16
Mark J Siedner, Mwebesa B Bwana, Mahomed-Yunus S Moosa, Michelle Paul, Selvan Pillay, Suzanne McCluskey, Isaac Aturinda, Kevin Ard, Winnie Muyindike, Pravikrishnen Moodley, Jaysingh Brijkumar, Tamlyn Rautenberg, Gavin George, Brent Johnson, Rajesh T Gandhi, Henry Sunpath, Vincent C Marconi
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. APPROACH: We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women...
July 18, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28718828/tobacco-harm-reduction-with-vaporised-nicotine-thrive-the-study-protocol-of-an-uncontrolled-feasibility-study-of-novel-nicotine-replacement-products-among-people-living-with-hiv-who-smoke
#17
Stephanie Bell, Judith Dean, Charles Gilks, Mark A Boyd, Lisa Fitzgerald, Allyson Mutch, Peter Baker, Graham Neilsen, Coral E Gartner
Smoking is a leading cause of morbidity and premature mortality among people living with HIV (PLHIV), who have high rates of tobacco smoking. Vaporised nicotine products (VNPs) are growing in popularity as a quit aid and harm reduction tool. However, little is known about their acceptability and use among PLHIV. Using a pragmatic, uncontrolled, mixed methods design this exploratory clinical trial aims to examine the feasibility of conducting a powered randomised clinical trial of VNPs as a smoking cessation and harm reduction intervention among vulnerable populations, such as PLHIV who smoke tobacco...
July 18, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28718495/comparative-effectiveness-of-single-and-dual-rapid-diagnostic-tests-for-syphilis-and-hiv-in-antenatal-care-services-in-colombia
#18
Hernando Guillermo Gaitán-Duarte, Lori Newman, Maura Laverty, Ndema Abu Habib, Lina María González-Gordon, Edith Ángel-Müller, Catleya Abella, Esther Cristina Barros, Carlos Rincón, Sidia Caicedo, Bertha Gómez, Freddy Pérez
Objective: To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. Methods: A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B)...
December 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28717981/effects-of-counselling-on-adherence-to-antiretroviral-treatment-among-people-with-hiv-in-estonia-a-randomized-controlled-trial
#19
Anneli Uusküla, Kaja-Triin Laisaar, Mait Raag, Liis Lemsalu, Liilia Lõhmus, Kristi Rüütel, K Rivet Amico
To assess the efficacy of an education- and strengths-based counselling programme to promote antiretroviral therapy (ART) adherence in a cohort of HIV-infected individuals with high prevalence of injection drug use in Estonia. Parallel-group randomized (1:1) controlled trial (RCT). Adults receiving ART in two clinics were followed for 12 months. The trial compared: (i) an intervention (three sessions) incorporated into routine clinic visits, providing education about HIV, ART, the role of adherence, and tailoring regimen to daily routines using problem-solving skills to address adherence barriers versus (ii) usual care (control)...
July 17, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28717861/patient-perspectives-on-gene-transfer-therapy-for-sickle-cell-disease
#20
Heather Strong, Monica J Mitchell, Alana Goldstein-Leever, Lisa Shook, Punam Malik, Lori E Crosby
INTRODUCTION: Sickle cell disease (SCD) is a chronic genetic disease with high morbidity and early mortality; it affects nearly 100,000 individuals in the USA. Bone marrow transplantation, the only curative treatment, is available to less than 20% of patients because of a number of access barriers. Gene transfer therapy (GTT) has been shown to be curative in animal models and is approved for use in humans for early-phase studies at a few centers. GTT would offer a more accessible treatment option available to all patients...
July 17, 2017: Advances in Therapy
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