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Anti-Retroviral Therapy

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81. Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen

participants Observational Model: Cohort Time Perspective: Retrospective Official Title: Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen Actual Study Start Date : July 25, 2018 Estimated Primary Completion Date : July 24, 2019 Estimated Study Completion Date : July 24, 2019 Resource links provided by the National Library of Medicine related topics: available for: Groups and Cohorts Go to Intervention Details: Drug (...) IPD: No Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Yes Additional relevant MeSH terms: Layout table for MeSH terms Cardiovascular Diseases Metabolic Syndrome Hyperglycemia Weight Gain Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Body Weight Changes Body Weight Signs and Symptoms Tenofovir Anti-Retroviral Agents

2018 Clinical Trials

82. Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients

continued) or switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens. Primary endpoint was HIV RNA <40 copies/mL at 48 weeks, with a non-inferiority margin of 12%. Changes of CD4 cell counts and lipid profiles from baseline were analyzed. Condition or disease Intervention/treatment Phase Efficacy of Rilpivirine-based Regimens as Switch Therapy Drug: Nevirapine Drug (...) : Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients With Complete Virological Suppression: A Randomized Controlled Trial Actual Study Start Date : December 1, 2016 Actual Primary Completion Date : October 31, 2017 Actual Study Completion Date : October 31, 2017 Resource links provided by the National Library of Medicine

2018 Clinical Trials

83. Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy (...) and plerixafor may work better in treating patients with glioblastoma. Condition or disease Intervention/treatment Phase Glioblastoma Glioblastoma With Primitive Neuronal Component Gliosarcoma Malignant Glioma Oligodendroglial Component Present Drug: Plerixafor Drug: Temozolomide Radiation: Whole-Brain Radiotherapy (WBRT) Radiation: Radiation Therapy Phase 2 Detailed Description: PRIMARY OBJECTIVES: I. To assess the 6 month progression-free survival (PFS) (post initiation of radiation) of continuous infusion

2018 Clinical Trials

84. Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe

Label) Primary Purpose: Treatment Official Title: Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe Actual Study Start Date : October 5, 2018 Estimated Primary Completion Date : January 1, 2020 Estimated Study Completion Date : January 1, 2020 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Problem (...) and tackle problems leading to sub-optimal antiretroviral therapy adherence. In the group activity, participants are taught an income generating skill and have the opportunity to share personal experience with former participants of the intervention. Other: Enhanced Standard of Care Study participants receive information on available routine services for common mental disorders, a nurse-led brief support counseling, assessment for antidepressant medication (fluoxetine) by the clinic nurse, and referral

2018 Clinical Trials

85. Uptake of antiretroviral therapy in HIV-positive women ever enrolled into 'prevention of mother to child transmission' programme, Mandalay, Myanmar-a cohort study. Full Text available with Trip Pro

Uptake of antiretroviral therapy in HIV-positive women ever enrolled into 'prevention of mother to child transmission' programme, Mandalay, Myanmar-a cohort study. Early initiation and longer duration of anti-retroviral therapy either as prophylaxis (pARV) or lifelong treatment (ART) in HIV-positive pregnant women prior to delivery has a huge impact in reducing mother to child transmission (MTCT) of HIV, maternal morbidity, mortality and increasing retention in care. In this study, we aimed

2018 BMC Pregnancy and Childbirth

86. Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

: 2017-11-10508 First Posted: March 5, 2018 Last Update Posted: August 17, 2018 Last Verified: August 2018 Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Sandra McCoy, University of California, Berkeley: HIV Food Insecurities Antiretroviral Therapy Additional relevant MeSH terms: Layout table for MeSH terms Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents (...) : Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania Actual Study Start Date : March 1, 2018 Estimated Primary Completion Date : June 30, 2019 Estimated Study Completion Date : June 30, 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Incentive for return to care Standard of care HIV primary care services, including counseling

2018 Clinical Trials

87. Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy

Antiretroviral Therapy Estimated Study Start Date : September 2018 Estimated Primary Completion Date : May 2020 Estimated Study Completion Date : May 2020 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Single group HIV-infected subjects with no previous ART will begin ART together with Vedolizumab infusions at week 0, 4, 8, 12, 16, 20 and 24 weeks. At this time point ART and Vedolizumab treatment (...) before the beginning of the study. Cardiovascular disease (e.g., acute coronary syndrome, heart failure…). Neurological or neuro psychiatric disorder which symptoms may interfere with the safety and tolerability analysis. Alcohol abuse and/or drugs that may interfere with the study treatment. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided

2018 Clinical Trials

88. MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Keywords provided by MacroGenics: HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy Additional relevant MeSH terms: Layout table for MeSH terms Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents (...) Purpose: Treatment Official Title: A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Actual Study Start Date : September 25, 2018 Estimated Primary Completion Date : March 2020 Estimated Study Completion Date : March 2020 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: MGD014 HIV-1 x CD3

2018 Clinical Trials

89. HIV-1-Gag Conserved-Element DNA Vaccine as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy

Diseases Vaccines Anti-Retroviral Agents Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents (...) muscles). Immune deficiency other than HIV. Breastfeeding or pregnancy. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Current HCV antiviral therapy. Type I or type II diabetes mellitus. Weight less than 50 kg or greater than 200 kg. Known to have been started on antiretroviral therapy within 3 months of the presumed or known date of first acquiring HIV-1 infection; i.e., treated during acute HIV-1 infection

2018 Clinical Trials

90. Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women

Previous use of injectable GAHT in the past 6 months Current use of any of the following medication: Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives Sedatives: Midazolam or triazolam Herbs: Gingko biloba, St John's wort or milk thistle Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin Alcohol or drug use that, in the opinion of the investigator, would (...) AIDS Research Centre ClinicalTrials.gov Identifier: Other Study ID Numbers: iFACT First Posted: August 8, 2018 Last Update Posted: October 29, 2018 Last Verified: August 2018 Additional relevant MeSH terms: Layout table for MeSH terms Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

2018 Clinical Trials

91. Tenofovir Combination or Mono-therapy for MDR CHB

] Actual Enrollment : 236 participants Observational Model: Cohort Time Perspective: Prospective Target Follow-Up Duration: 5 Years Official Title: Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study Actual Study Start Date : June 1, 2013 Estimated Primary Completion Date : December 31, 2018 Estimated Study Completion Date : December 31, 2019 Resource links provided by the National Library of Medicine related (...) related or not related to the study medication Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 19 Years

2018 Clinical Trials

92. Interventions to Improve HIV Antiretroviral Therapy Adherence

Collaborator: Beira Operational Research Center Information provided by (Responsible Party): James Riddell, University of Michigan Study Details Study Description Go to Brief Summary: This study will explore whether financial incentives and reminders help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment (...) Estimated Primary Completion Date : August 2019 Estimated Study Completion Date : August 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Financial Incentive Group Behavioral: Financial Incentive Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months Experimental: Reminders Group Behavioral: Reminders Reminders

2018 Clinical Trials

93. A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients

any of the following criteria will be excluded from participating in this study: Glucose-6-phosphate dehydrogenase (G6PD) deficiency HIV positive individuals requiring anti-retroviral drug therapy (high-dose ascorbate is known to interact with many of these drugs) Platelet count of <100,000 k/mm3 Prior radiation that would result in field overlap (this will be determined by the study's radiation oncologist) Actively receiving insulin Other therapy (including radiation therapy) within 2 calendar (...) and chemotherapy for treatment of pancreatic cancer. Condition or disease Intervention/treatment Phase Pancreatic Neoplasm Drug: Ascorbate Drug: Gemcitabine Radiation: radiation therapy Phase 2 Detailed Description: This phase 2 study is designed to determine the efficacy of adding pharmacological ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused before, during, and after the external beam radiation therapy treatment. Each ascorbate infusion is 75 grams (roughly the same amount

2018 Clinical Trials

94. Evaluating Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected Individuals

) antiretroviral therapy (ART) and all-oral standard of care (SOC). Condition or disease Intervention/treatment Phase HIV Infections Drug: Standard of Care (SOC) Oral ART Drug: Oral RPV Drug: Oral CAB Drug: RPV-LA Loading Dose Drug: CAB-LA Loading Dose Drug: RPV-LA Maintenance Dose Drug: CAB-LA Maintenance Dose Phase 3 Detailed Description: This study will compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control (...) of their HIV infection: long-acting (LA) antiretroviral therapy (ART) with rilpivirine (RPV) LA and cabotegravir (CAB) LA versus all-oral standard of care (SOC). The study includes four steps. In Step 1, participants will receive a SOC oral induction regimen consisting of an ART regimen that involves at least 3 drugs for 24 weeks. Participants who achieve milestones will receive conditional economic incentives at Weeks 2, 4, 8, 12, 16, and 20. In Step 2, eligible participants will be randomized to receive

2018 Clinical Trials

95. Effects of undernutrition on survival of human immunodeficiency virus positive children on antiretroviral therapy Full Text available with Trip Pro

Effects of undernutrition on survival of human immunodeficiency virus positive children on antiretroviral therapy The relationship between undernutrition and HIV is bidirectional, ultimately contributing to quality of life and survival of affected individuals. Ethiopia is a sub-Saharan nation influenced by both undernutrition and HIV. In Ethiopia, although individuals are often dually impacted, the effect of undernutrition on the survival of HIV positive children on anti-retroviral therapy (ART

2018 Italian journal of pediatrics

96. Preliminary Data From the Study of Coagulative Profile of HIV Infected Individuals Suggest a Role For Point Mutations in the Gene in Protein S Deficiency in Individuals Undergoing Highly Antiretroviral Therapy Full Text available with Trip Pro

with different anti-retroviral regimens.Forty-four patients were included in the study. C and PS, D-Dimers and Fibrinogen levels were determined as well as APC-resistance. PROS1 gene was sequenced in a group of patient.Twelve of the 44 subjects (27%) showed reduced levels of PS, while lower levels of PC were found only in 2 patients (4,5%). No difference in the mean values of PC and PS was found stratifying the study population by antiretroviral regimen administrated (p>0.05).Three patients had higher levels (...) Preliminary Data From the Study of Coagulative Profile of HIV Infected Individuals Suggest a Role For Point Mutations in the Gene in Protein S Deficiency in Individuals Undergoing Highly Antiretroviral Therapy HIV infection is a known prothrombotic condition but factors involved are still controversial. A role for antiretrovirals, especially protease inhibitors, was advocated.The study aimed to analyze the levels of anticoagulant proteins in virally suppressed HIV-infected subjects treated

2018 The open AIDS journal

97. Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany

Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany Actual Study Start Date : November 13, 2018 Estimated Primary Completion Date : December 1, 2021 Estimated Study Completion Date : December 1, 2021 Resource links provided by the National Library of Medicine related topics: available for: Groups and Cohorts Go to Group/Cohort Intervention/treatment Treatment naïve subjects with HIV infection Treatment (...) ) will be summarized. Number and frequency of serious adverse events (SAE) [ Time Frame: Up to 36 months ] An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Number and frequency of adverse drug reactions (ADRs) [ Time Frame: Up to 36 months ] An ADR is defined as a noxious and unintended response

2018 Clinical Trials

98. Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

-proven Kaposi sarcoma with associated leg lymphedema Leg lymphedema consistent with Campisi Clinical Stage 1B, 2, 3, 4 (Table 4). At these stages, lymphedema is clinically evident and not yet permanently fibrotic, sclerotic, or indurated with verrucous change. HIV positive On highly active anti-retroviral therapy About to initiate a course of chemotherapy Willingness to participate for the entire study duration, ranging from at least 14 weeks and up to 24 weeks, depending on randomization. Provision (...) Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya Actual Study Start Date : March 1, 2018 Estimated Primary Completion Date : December 31, 2019 Estimated Study Completion Date : June 15, 2020 Resource links provided by the National Library of Medicine related topics: related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Immediate Compression Therapy Arm Patients in this arm will receive a locally

2018 Clinical Trials

99. Pulmonary hypertension in patients with a history of intravenous drug use. (Abstract)

with relevant key terms and various synonyms.HIV infection may be associated with pulmonary hypertension due to indirect consequences of viral infection, venous thromboembolism, or its therapies. Anti-retroviral infection may also influence plasma concentrations of commonly used treatments for pulmonary hypertension. Intravenous drug use is acknowledged as an important portal for the acquisition of hepatitis virus C infection, with portopulmonary hypertension a potential complication associated with poor (...) prognosis. Interferon based therapy, used in treatment of chronic hepatitis C infection may also play a casual role in the development of pulmonary hypertension. More recently, sofosbuvir has been linked to development or exacerbation of pulmonary arterial hypertension. Certain drugs of abuse may cause pulmonary hypertension due to properties that result in direct injury to the pulmonary vasculature. The potential for embolic phenomena, complicating venous thromboembolism, recurrent embolization

2018 Current medical research and opinion

100. The infection staging and profile of genotypic distribution and drug resistance mutation among the human immunodeficiency virus-1 infected blood donors from five Chinese blood centers, 2012-2014. Full Text available with Trip Pro

infections. 31 DRMs were identified from 27 samples including four protease inhibitors (PIs) accessory DRMs, two PIs major DRMs (M46I), two nucleoside RT inhibitors DRMs (K219R and K70Q), and 23 nonnucleoside RT inhibitors DRMs. 27 samples had DRMs, yielding a drug resistance prevalence of 13.2% (27/205). Our findings provide important information for developing strategies for comprehensive HIV control and improving anti-retroviral treatment in China. (...) The infection staging and profile of genotypic distribution and drug resistance mutation among the human immunodeficiency virus-1 infected blood donors from five Chinese blood centers, 2012-2014. The increasing complexity and diversity of the human immunodeficiency virus-1 (HIV-1) infections challenge the disease control and anti-retrovirus treatment in China. The infection stages and molecular characteristics of HIV-1 from infected Chinese blood donors were examined to shed light on the HIV

2017 PLoS ONE

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