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Lamivudine

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41. Doravirine exposure and HIV-1 suppression after switching from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate. Full Text available with Trip Pro

Doravirine exposure and HIV-1 suppression after switching from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate. Doravirine is a non-nucleoside reverse transcriptase inhibitor approved for the treatment of HIV-1. In a phase 1 trial, doravirine exposure was transiently decreased when treatment was started immediately after stopping efavirenz. In a post-hoc subgroup analysis of participants who switched from an efavirenz-based regimen to doravirine/lamivudine

2019 Antimicrobial Agents and Chemotherapy

42. No meaningful drug interactions with doravirine, lamivudine and tenofovir disoproxil fumarate co-administration. Full Text available with Trip Pro

No meaningful drug interactions with doravirine, lamivudine and tenofovir disoproxil fumarate co-administration. Doravirine (DOR) is a novel non-nucleoside reverse transcriptase inhibitor available as a single tablet and a three-drug combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) to treat HIV-1 infection. These analyses assessed pharmacokinetic (PK) interactions with co-administration.Two trials were conducted. Study 1: two-period, fixed-sequence; 8 healthy

2019 Antiviral Therapy Controlled trial quality: uncertain

43. Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen. (Abstract)

Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen. To evaluate the efficacy and safety of switching from an abacavir/lamivudine (ABC/3TC)-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen in virologically suppressed, HIV-1-infected adults.Randomized, open-label, noninferiority

2019 AIDS Controlled trial quality: uncertain

44. Pharmacokinetic profiles of boosted darunavir, dolutegravir and lamivudine in aging patients enrolled in the Swiss HIV Cohort Study. (Abstract)

Pharmacokinetic profiles of boosted darunavir, dolutegravir and lamivudine in aging patients enrolled in the Swiss HIV Cohort Study. The pharmacokinetics (PK) of antiretroviral drugs may differ in elderly people living with HIV (PLWH) due to age related physiological changes. We aimed to assess the PK of several antiretroviral drugs in aging PLWH enrolled in the Swiss HIV Cohort (SHCS).Full PK profiling nested in a multicenter, observational, prospective cohort study. Additional collection (...) were collected for 804 PLWH with a median age of 52. Boosted darunavir clearance was 40% lower in aging (≥ 65 years) compared to younger (< 65 years) PLWH, consistent with other drugs predominantly metabolized by CYP3A. Dolutegravir exposure was similar between age groups whereas lamivudine exposure increased by 11% in aging PLWH. Median boosted darunavir, dolutegravir and lamivudine t1/2 were 148%, 45% and 32% higher in aging compared to younger PLWH.Advanced age did not affect boosted darunavir

2019 AIDS

45. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phas (Abstract)

Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phas Bictegravir, co-formulated with emtricitabine and tenofovir alafenamide, has shown good efficacy and tolerability, and similar bone, renal, and lipid profiles to dolutegravir, abacavir, and lamivudine, in treatment-naive adults with HIV-1 (...) infection, without development of treatment-emergent resistance. Here, we report 48-week results of a phase 3 study investigating switching to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine in virologically suppressed adults with HIV-1 infection.In this multicentre, randomised, double-blind, active-controlled, non-inferiority, phase 3 trial, HIV-1-infected adults were enrolled at 96 outpatient centres in nine countries. Eligible participants were aged

2019 The lancet. HIV Controlled trial quality: predicted high

46. Switching Lamivudine with Adefovir Dipivoxil Combination Therapy to Entecavir Monotherapy Provides Better Viral Suppression and Kidney Safety. Full Text available with Trip Pro

Switching Lamivudine with Adefovir Dipivoxil Combination Therapy to Entecavir Monotherapy Provides Better Viral Suppression and Kidney Safety. Introduction: Most chronic hepatitis B (CHB) patients in China are primitively treated with a combination of lamivudine (LAM) and adefovir dipivoxil (ADV). Although antiviral resistance can be avoided with this combination therapy, using it can have harmful side effects related to ADV, specifically kidney and bone injury. This study was designed

2019 International journal of medical sciences

47. Dolutegravir monotherapy versus dolutegravir/abacavir/lamivudine for virologically suppressed people living with chronic HIV infection: the randomized non-inferiority MONCAY trial. (Abstract)

Dolutegravir monotherapy versus dolutegravir/abacavir/lamivudine for virologically suppressed people living with chronic HIV infection: the randomized non-inferiority MONCAY trial. We investigated whether dolutegravir monotherapy was able to maintain virological suppression in people living with HIV on a successful dolutegravir-based triple-therapy.MONCAY was a 48-week multicentric, randomized, open-label, 12% non-inferiority margin trial. Patients with CD4 nadir>100/μL, plasma HIV-1 RNA <50 (...) copies/mL for ≥12 months and stable regimen with dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) were 1:1 randomized to continue their regimen or to DTG monotherapy. The primary endpoint was the proportion of patients with HIV RNA <50 copies/mL at week (W) 24 in intention-to-treat (ITT) snapshot analysis. Virologic failure (VF) was defined as two consecutive HIV-RNA >50 copies/mL within 2 weeks apart.Seventy-eight patients were assigned to DTG monotherapy and 80 to continue DTG/ABC/3TC. By W24, two

2019 Clinical Infectious Diseases Controlled trial quality: uncertain

48. Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA &lt;500 000 copies/mL: week 48 outcomes from ACTG 5353. Full Text available with Trip Pro

Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353. The AIDS Clinical Trials Group study A5353 demonstrated the efficacy and safety of dolutegravir and lamivudine for initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA 1000-500 000 copies/mL. Optimal ART for treatment-naive individuals must be durable.The aim of this study was to estimate the efficacy and safety (...) of dolutegravir plus lamivudine at week 48 and compare the efficacy in participants with baseline HIV-1 RNA ≤100 000 copies/mL versus >100 000 copies/mL.Virological success was defined as HIV-1 RNA <50 copies/mL by FDA Snapshot criteria. Definition of virological failure included confirmed HIV-1 RNA >200 copies/mL at week 24 or later. The proportion of participants with virological success was estimated using two-sided exact Clopper-Pearson 95% CI. Comparison between screening HIV-1 RNA (≤100 000 versus >100

2019 Journal of Antimicrobial Chemotherapy

49. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. (Abstract)

Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low (...) adults (aged ≥18 years) who were previously untreated (HIV-1 RNA ≥500 copies per mL); HLA-B*5701-negative; had no hepatitis B virus infection; screening genotypes showing sensitivity to emtricitabine, tenofovir, lamivudine, and abacavir; and an estimated glomerular filtration rate of 50 mL/min or more. Participants were randomly assigned (1:1), via a computer-generated allocation sequence (block size of four), to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide

2017 Lancet Controlled trial quality: predicted high

50. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. (Abstract)

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Bictegravir co-formulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination is recommended for treatment of HIV-1-infection and might be better tolerated than other integrase inhibitor-based single-tablet regimens, but long-term (...) outcomes data are not available. We assessed the efficacy, safety and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine at week 96.This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 122 outpatient centres in nine countries. We enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus

2019 The lancet. HIV Controlled trial quality: predicted high

51. Comparable viral decay with initial dolutegravir plus lamivudine versus dolutegravir-based triple therapy. (Abstract)

Comparable viral decay with initial dolutegravir plus lamivudine versus dolutegravir-based triple therapy. To expand understanding of the virological potency of initial dolutegravir plus lamivudine dual therapy (dolutegravir/lamivudine), we compared the viral decay seen in the pilot ACTG A5353 study with the decay observed with dolutegravir plus two NRTIs in the SPRING-1 and SINGLE studies, while also exploring the impact of baseline viral load (VL).Change in VL from baseline was calculated (...) for timepoints shared by A5353 (n = 120, including 37 participants with pretreatment VL >100 000 copies/mL), SPRING-1 (n = 51) and SINGLE (n = 417). The 95% CIs of change from baseline were determined for each observed week, using the mean log10-transformed VL, and compared between the dolutegravir/lamivudine and triple therapy groups using the Wilcoxon Rank Sum test for non-inferiority (δ = 0.5). To assess the impact of baseline VL on viral decay, we examined a bi-exponential non-linear mixed-effect

2019 Journal of Antimicrobial Chemotherapy

52. The Effect of Prophylactic Lamivudine plus Adefovir Therapy Compared with Lamivudine Alone in Preventing Hepatitis B Reactivation in Lymphoma Patients with High Baseline HBV DNA during Chemotherapy. Full Text available with Trip Pro

The Effect of Prophylactic Lamivudine plus Adefovir Therapy Compared with Lamivudine Alone in Preventing Hepatitis B Reactivation in Lymphoma Patients with High Baseline HBV DNA during Chemotherapy. Prophylactic antiviral therapy is essential for lymphoma patients with high baseline HBV DNA who undergo cytotoxic chemotherapy. However, there are limited data on the optimal options. The present study was designed to compare the efficacy of prophylactic lamivudine (LAM) with lamivudine plus

2016 PLoS ONE

53. Clinical effect of lamivudine in treating liver function lesion caused by hepatitis B combined with Anti-TB drugs. (Abstract)

Clinical effect of lamivudine in treating liver function lesion caused by hepatitis B combined with Anti-TB drugs. The present study is designed to conduct, the analysis on the curative effect of Lamivudine in treating liver function lesion caused by hepatitis B combined anti-TB drugs. The 4200 patients who have been treated for hepatitis B combined with pulmonary TB in 8 different hospitals from Feb 2014 to Feb 2016 were selected as research objects. They were randomly divided into control (...) group and observation group, each containing 2100 patients. In control group, patients were applied with conventional Anti-TB therapy and liver-protecting therapy; while in observation group, patients were applied with lamivudine in addition to conventional therapies. The variations of liver functions of both groups before and after therapies were observed. After treatment, the liver function lesions of patients in observation group were significantly lower than that in control group; moreover

2018 Pakistan journal of pharmaceutical sciences Controlled trial quality: uncertain

54. Similar neurocognitive outcomes after 48 weeks in HIV-1-infected participants randomized to continue tenofovir/emtricitabine + atazanavir/ritonavir or simplify to abacavir/lamivudine + atazanavir. Full Text available with Trip Pro

Similar neurocognitive outcomes after 48 weeks in HIV-1-infected participants randomized to continue tenofovir/emtricitabine + atazanavir/ritonavir or simplify to abacavir/lamivudine + atazanavir. Human immunodeficiency virus (HIV)-associated neurocognitive disorders can persist in many patients despite achieving viral suppression while on antiretroviral therapy (ART). Neurocognitive function over 48 weeks was evaluated using a Cogstate test battery assessing psychomotor function, attention (...) , learning, and working memory in 293 HIV-1-infected, ART-experienced, and virologically suppressed adults. The ASSURE study randomized participants 1:2 to remain on tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV). Neurocognitive z-scores were computed using demographically adjusted normative data and were classified as "impaired" (defined as either a z-score ≤ - 2 or having 2 or more standardized individual test z

2018 Journal of neurovirology Controlled trial quality: uncertain

55. [Efficacy and safety of Entecavir monotherapy switched from Lamivudine combined Adefovir Dipivoxil for chronic hepatitis B virus-related compensated liver cirrhosis]. (Abstract)

[Efficacy and safety of Entecavir monotherapy switched from Lamivudine combined Adefovir Dipivoxil for chronic hepatitis B virus-related compensated liver cirrhosis]. Objective: To observe the efficacy and safety of de novo combination of Lamivudine(LAM) and Adefovir Dipivoxil (ADV) therapy counter to Entecavir (ETV) monotherapy in patients with chronic hepatitis B (CHB)- related compensated liver cirrhosis. Methods: Patients with chronic hepatitis B-related compensated cirrhosis who were

2018 Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology Controlled trial quality: uncertain

56. [Compare the effect of combined therapy between telbivudine plus adefovir dipivoxil and lamivudine plus adefovir dipivoxil corresponding to renal function in patients with hepatitis B virus infection]. (Abstract)

[Compare the effect of combined therapy between telbivudine plus adefovir dipivoxil and lamivudine plus adefovir dipivoxil corresponding to renal function in patients with hepatitis B virus infection]. Objective: To compare the effect of combined therapy using lamivudine (LAM) plus adefovir (ADV) versus telbivudine (LdT) plus adefovir corresponding to the renal function of CHB patients. Methods: A total of 120 patients with chronic hepatitis B were enrolled. According to single daily dosing

2018 Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology

57. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Full Text available with Trip Pro

Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Abacavir and tenofovir alafenamide offer reduced bone toxicity compared with tenofovir disoproxil fumarate. We aimed to compare safety and efficacy of tenofovir alafenamide plus emtricitabine with that of abacavir plus lamivudine.In this randomised, double-blind, active-controlled (...) , non-inferiority phase 3 trial, HIV-1-positive adults (≥18 years) were screened at 79 sites in 11 countries in North America and Europe. Eligible participants were virologically suppressed (HIV-1 RNA <50 copies per mL) and on a stable three-drug regimen containing abacavir plus lamivudine. Participants were randomly assigned (1:1) by a computer-generated allocation sequence (block size 4) to switch to fixed-dose tablets of tenofovir alafenamide (10 mg or 25 mg) plus emtricitabine (200 mg) or remain

2018 The lancet. HIV Controlled trial quality: predicted high

58. Observation of combined/optimized therapy of Lamivudine and Adefovir Dipivoxyl for hepatitis B-induced decompensated cirrhosis with baseline HBV DNA>1,000 IU/mL. (Abstract)

Observation of combined/optimized therapy of Lamivudine and Adefovir Dipivoxyl for hepatitis B-induced decompensated cirrhosis with baseline HBV DNA>1,000 IU/mL. This study aimed to observe and compare the efficacy and safety of the combined therapy and two different optimized therapies of lamivudine (LAM) and adefovir dipivoxil (ADV), as well as entecavir (ETV) monotherapy in patients with hepatitis B-induced decompensated cirrhosis. Method : A total of 127 patients with decompensated

2018 Acta gastro-enterologica Belgica Controlled trial quality: uncertain

59. Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults. Full Text available with Trip Pro

Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults. The fixed-dose combination (FDC) tablet formulation of abacavir/dolutegravir/lamivudine is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing ≥40 kg. Alternative formulations with acceptable palatability and convenient dosing are needed for children who require smaller doses and have (...) difficulty swallowing tablets.A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets.The test treatments were 4 dispersible FDC tablets reconstituted in water with high- or zero-mineral content and administered either

2018 Journal of acquired immune deficiency syndromes (1999) Controlled trial quality: uncertain

60. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Full Text available with Trip Pro

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Doravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), is active against wild-type Human Immunodeficiency Virus (HIV)-1 and the most common NNRTI-resistant variants, and has a favorable and unique in vitro resistance profile.DRIVE (...) -AHEAD is a phase 3, double-blind, non-inferiority trial. Antiretroviral treatment-naive adults with ≥1000 HIV-1 RNA copies/mL were randomized (1:1) to once-daily, fixed-dose DOR at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR/3TC/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV/FTC/TDF) for 96 weeks. The primary efficacy endpoint was the proportion of participants with <50 HIV-1 RNA copies/mL at week 48 (Food and Drug

2018 Clinical Infectious Diseases Controlled trial quality: predicted high

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