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Anti-Retroviral Therapy

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161. Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication

to Share IPD: No Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No Additional relevant MeSH terms: Layout table for MeSH terms Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Tenofovir Anti-Retroviral Agents Insulin Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme (...) : QD Masking: None (Open Label) Primary Purpose: Treatment Official Title: Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication: The TAF-IR Study Actual Study Start Date : April 18, 2017 Actual Primary Completion Date : July 28, 2017 Actual Study Completion Date : July 28, 2017 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment

2017 Clinical Trials

162. Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A

Diseases Metabolism, Inborn Errors Lenograstim Sargramostim Plerixafor octahydrochloride Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents (...) Go to Brief Summary: This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the FANCA gene for patients with Fanconi Anemia of Subtype A . CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a lentiviral vector carrying the gene FANCA

2017 Clinical Trials

163. Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care

Phase Human Immunodeficiency Virus HIV/AIDS Behavioral: Social Network Training Behavioral: Single Care-Related Counseling Session and Referral to Care Not Applicable Detailed Description: Phase I of the planned research will be the conduct of in-depth interviews with 30 HIV+ persons not in medical care or not adherent to anti-retroviral therapy (ART) regimens, including men and women representing diverse exposure risks (drug use, men who have sex with men, and heterosexual transmission). Interviews (...) to sustain friends' medical care engagement. Intervention outcomes will be determined by baseline to 6- and 12-month followup change on primary measures of participant attendance at HIV medical care visits, adherence to ART regimens, and viral load as well as secondary measures of alcohol use, drug use, sexual risk behavior, treatment attitudes, and psychosocial distress. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 320

2017 Clinical Trials

164. HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia

IPD: Undecided Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents (...) University Teaching Hospital (UTH) Internal Medicine wards which can inform development of a linkage intervention. Our central hypothesis is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis. Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical factors

2017 Clinical Trials

165. Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X)

information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders Emtricitabine Darunavir Maraviroc Cobicistat Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV (...) : March 30, 2019 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment No Intervention: Standard of care Continue current antiretroviral regimen Experimental: Reduced Neurotoxicity Arm Emtricitabine plus darunavir/cobicistat plus maraviroc Drug: emtricitabine, darunavir/cobicistat, maraviroc Treatment change Outcome Measures Go to Primary Outcome Measures : 6-month variation in global deficit score

2017 Clinical Trials

166. A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

combination anti-retroviral therapy. Current or the history of brain metastases or central nervous system (CNS) diseases Have undergone allogeneic stem cell transplant Relapsed less than 75 days from time of autologous stem cell transplant Patients with uncontrolled hypertension, active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to receive protocol treatment Had major surgery within 2 weeks (...) Intervention/treatment Phase Peripheral T Cell Lymphoma Progression, Disease Drug: Pralatrexate Phase 4 Detailed Description: Peripheral T-cell lymphomas (PTCL) are a group of aggressive and diverse lymphoproliferative disorders. It is characterized by the presence of malignant mature T-cells or NK cells. There is as yet no consensus regarding standard frontline or relapsed/refractory therapy for PTCL. A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed

2017 Clinical Trials

167. Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected

Responsible Party: Hospital General Universitario Gregorio Marañon ClinicalTrials.gov Identifier: Other Study ID Numbers: FIBHGM-EONC001-2016 First Posted: June 9, 2017 Last Update Posted: June 12, 2017 Last Verified: June 2017 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Anti (...) Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number

2017 Clinical Trials

168. Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection

syndrome (AIDS). HIV infects cells of the immune system throughout the body and may cause an active cytolytic infection in activated lymphocytes, become dormant as a latent infection in resting lymphocytes, or continue as a chronically active infection in macrophages. Continuous anti-retroviral drug treatment (ART) suppresses virus within the bloodstream and allows some degree of immune healing so as to permit near-normal health and life expectancy. However, interruption of ART is uniformly followed (...) Masking: None (Open Label) Primary Purpose: Treatment Official Title: Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection Actual Study Start Date : November 1, 2017 Estimated Primary Completion Date : December 31, 2018 Estimated Study Completion Date : December 31, 2018 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: vedolizumab infusions and ATI The study will have

2017 Clinical Trials

169. Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in HIV-Infected Infants Receiving Combination Antiretroviral Therapy

table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Antibodies Antibodies, Monoclonal Anti-Retroviral Agents Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents (...) activity of VRC01 in HIV-1-infected infants beginning combination antiretroviral therapy (cART). Condition or disease Intervention/treatment Phase HIV Infections Biological: VRC01 Drug: Combination Antiretroviral Therapy (cART) Phase 1 Phase 2 Detailed Description: VRC01 is an experimental human immunoglobulin G1 (IgG1) monoclonal antibody. The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in HIV-1-infected infants initiating cART within 12 weeks of birth. The infants

2017 Clinical Trials

170. Optimization of Darunavir Therapy and Dosage Recommendations

Catholique de Louvain Information provided by (Responsible Party): Laure Elens, Université Catholique de Louvain Study Details Study Description Go to Brief Summary: This study will assess and characterize the variability observed in the response to darunavir therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV). More specifically, it aims to quantify variations in the drug's blood concentrations and determine the sources of such variability, both genetic and non (...) Modeling, Simulations and Dosage Guidelines Actual Study Start Date : March 23, 2017 Estimated Primary Completion Date : March 2019 Estimated Study Completion Date : March 2019 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Darunavir All patients treated with darunavir Drug: Darunavir The investigated drugs are Prezista (darunavir 600 mg twice-daily or 800 mg once-daily) and Rezolsta (darunavir 800 mg

2017 Clinical Trials

171. Timing of Referral to Adherence Clubs for Antiretroviral Therapy

of Cape Town Collaborator: Medical Research Council Information provided by (Responsible Party): Professor Landon Myer, University of Cape Town Study Details Study Description Go to Brief Summary: Following the announcement of the global "90-90-90" strategy, there is a huge need in South Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy) delivery that aim to improve patient adherence and viral suppression. The ART adherence club is one such model of service delivery (...) : Adherence Club Not Applicable Detailed Description: Following on from the huge need for scaled-up models of ART (anti-retroviral therapy) delivery to improve patient adherence and viral suppression, the ART adherence club model was piloted from 2007 with the aim of assessing whether this group-based, lay-counsellor led service, with an emphasis on social support and adherence, could help address retention in care and viral suppression. Since the initial pilots, the club model has been scaled up rapidly

2017 Clinical Trials

172. Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

Diseases (NIAID) ) Study Details Study Description Go to Brief Summary: Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some people develop resistance to the drugs or have permanent side effects. Objective: To study the impact of a short-term treatment stop (...) and then monthly for about 11 months. Participants will have blood drawn, physical exam, and medical history. They will have leukapheresis 2 more times over 1 year. Condition or disease HIV Detailed Description: While antiretroviral therapy (ART) has improved the clinical outcome for HIV-infected individuals, persistence of viral reservoirs in the peripheral blood and lymphoid tissues remains a hurdle to the eradication of virus. The vast majority of HIV-infected individuals treated with ART experience plasma

2017 Clinical Trials

173. MDM2 Inhibitor AMG-232 and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

virus (HIV) are NOT excluded from this study, but HIV-positive patients must have: A stable regimen of highly active anti-retroviral therapy (HAART) No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based test HIV testing is not required Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 (...) AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Condition or disease Intervention/treatment Phase Soft Tissue Sarcoma Other: Laboratory Biomarker Analysis Drug: MDM2 Inhibitor AMG-232 Other: Pharmacological Study Radiation: Radiation Therapy Phase 1 Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of MDM2 inhibitor AMG-232 (AMG 232) in combination with standard-dose

2017 Clinical Trials

174. Postpartum Adherence Clubs for Antiretroviral Therapy

, University of Cape Town: therapy postnatal Additional relevant MeSH terms: Layout table for MeSH terms Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents (...) Therapy (PACART) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03200054 Recruitment Status : Active, not recruiting First Posted : June 27, 2017 Last Update Posted : November 9, 2018 Sponsor: University of Cape Town Collaborator: Medical Research Council Information provided by (Responsible Party

2017 Clinical Trials

175. A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir

of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GlaxoSmithKline medical monitor, the medication (...) distilled spirits. Regular use of tobacco- or nicotine- containing products within 6 months prior to screening. Unable to refrain from smoking from the Screening Visit through the last blood sample collected. As confirmed by a urine cotinine test. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. Presence of hepatitis B surface antigen (HBsAg

2017 Clinical Trials

176. Effectiveness of isoniazid preventative therapy in reducing incidence of active tuberculosis among people living with HIV/AIDS in public health facilities of Addis Ababa, Ethiopia: a historical cohort study. Full Text available with Trip Pro

. The aIRR among patients who took Highly Active Anti- Retroviral Therapy (HAART) with IPT compared to those who took HAART alone was 0.063 (95% CI 0.035-0.104). IPT significantly reduced occurrence of active TB for 3 years.IPT significantly reduced tuberculosis incidence by 96.3% compared to IPT non-exposed patients. Moreover concomitant use of HAART with IPT has shown a significant reduction in tuberculosis incidence by 93.7% than the use of HAART alone. Since IPT significantly protected occurrence (...) Effectiveness of isoniazid preventative therapy in reducing incidence of active tuberculosis among people living with HIV/AIDS in public health facilities of Addis Ababa, Ethiopia: a historical cohort study. Human Immunodeficiency Virus (HIV) pandemic has exacerbated tuberculosis disease especially in Sub-Saharan African countries. The World Health Organization (WHO) and Joint United Nations Program on HIV/AIDS (UNAIDS) have recommended Isoniazid Preventive Therapy (IPT) for HIV infected

2017 BMC Infectious Diseases

177. Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy

Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number (...) of saved studies (100). Please remove one or more studies before adding more. Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (TRULIGHT) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02302547 Recruitment Status : Completed First

2014 Clinical Trials

178. Antiretroviral Therapy in Early HIV Infection. Full Text available with Trip Pro

Antiretroviral Therapy in Early HIV Infection. 26816020 2016 01 28 2018 12 02 1533-4406 374 4 2016 01 28 The New England journal of medicine N. Engl. J. Med. Antiretroviral Therapy in Early HIV Infection. 393 10.1056/NEJMc1513311 Lopez-Cortes Luis F LF Gutiérrez-Valencia Alicia A Ben-Marzouk-Hidalgo Omar J OJ eng Letter Comment United States N Engl J Med 0255562 0028-4793 0 Anti-Retroviral Agents AIM IM N Engl J Med. 2015 Aug 27;373(9):795-807 26192873 N Engl J Med. 2016 Jan 28;374(4):394 (...) 26816019 Anti-Retroviral Agents administration & dosage Female HIV Seropositivity drug therapy Humans Male 2016 1 28 6 0 2016 1 28 6 0 2016 1 29 6 0 ppublish 26816020 10.1056/NEJMc1513311 10.1056/NEJMc1513311#SA1

2016 NEJM

179. Antiretroviral Therapy in Early HIV Infection. Full Text available with Trip Pro

Antiretroviral Therapy in Early HIV Infection. 26816021 2016 01 28 2018 12 02 1533-4406 374 4 2016 01 28 The New England journal of medicine N. Engl. J. Med. Antiretroviral Therapy in Early HIV Infection. 393-4 10.1056/NEJMc1513311 Corrao Salvatore S Prestileo Tullio T Di Lorenzo Francesco F eng Letter Comment United States N Engl J Med 0255562 0028-4793 0 Anti-Retroviral Agents AIM IM N Engl J Med. 2015 Aug 27;373(9):795-807 26192873 N Engl J Med. 2016 Jan 28;374(4):394 26816019 Anti (...) -Retroviral Agents administration & dosage Female HIV Seropositivity drug therapy Humans Male 2016 1 28 6 0 2016 1 28 6 0 2016 1 29 6 0 ppublish 26816021 10.1056/NEJMc1513311 10.1056/NEJMc1513311#SA2

2016 NEJM

180. 10-Year Survival of Patients with AIDS Receiving Antiretroviral Therapy in Haiti. Full Text available with Trip Pro

Immunodeficiency Syndrome drug therapy mortality Adult Anti-Retroviral Agents therapeutic use Developing Countries Female Haiti epidemiology Humans Male Survival Rate 2016 1 28 6 0 2016 1 28 6 0 2016 2 18 6 0 ppublish 26816026 10.1056/NEJMc1508934 PMC4824285 NIHMS762898 N Engl J Med. 2005 Dec 1;353(22):2325-34 16319381 J Acquir Immune Defic Syndr. 2006 Feb 1;41(2):194-200 16394852 N Engl J Med. 2009 Aug 20;361(8):828-9 19692699 (...) 10-Year Survival of Patients with AIDS Receiving Antiretroviral Therapy in Haiti. 26816026 2016 02 16 2018 11 13 1533-4406 374 4 2016 Jan 28 The New England journal of medicine N. Engl. J. Med. 10-Year Survival of Patients with AIDS Receiving Antiretroviral Therapy in Haiti. 397-8 10.1056/NEJMc1508934 Pierre Samuel S Groupe Haïtien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti. Jannat-Khah Deanna D Fitzgerald Daniel W DW Pape Jean J McNairy

2016 NEJM

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