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12 Diseases |  |
2 Trials |
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2 Trials |  |
675 News |  |
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- | Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Biomarker, Journal: HIV Integrase Inhibitor Pharmacogenetics: An Exploratory Study. (Pubmed Central) - Apr 9, 2019
The associations found in this study point to a need for further assessment, within the population living with HIV, of factors contributing to unfavorable subject outcomes. These exploratory findings require confirmation in larger studies, which then may investigate pharmacogenetic mechanisms.
- | Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Review, Journal: Structure Based Drug Design: Clinically relevant HIV1 Integrase Inhibitors. (Pubmed Central) - Apr 9, 2019
Into the bargain, Raltegravir, Elvitegravir and Dolutegravir have been approved by FDA as anti-HIV agents...Additionally, the structural features required for overcoming HIV resistance have been discussed. These insights will update the ongoing design of novel antiviral inhibitors.
- | Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Risk and Cost Associated With Drug-Drug Interactions Among Aging HIV Patients Receiving Combined Antiretroviral Therapy in France. (Pubmed Central) - Apr 6, 2019
Compared with propensity score-matched PLWH without DDIs, the presence of DDIs was associated with a $2693 additional cost per year (P < .0001). The presence of DDIs is frequent and significantly increases health care costs in the aging population of PLWH.
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Preclinical, Journal: Antiretroviral Hydrophobic Core Graft-Copolymer Nanoparticles: The Effectiveness against Mutant HIV-1 Strains and in Vivo Distribution after Topical Application. (Pubmed Central) - Apr 5, 2019
The presence of DDIs is frequent and significantly increases health care costs in the aging population of PLWH. insoluble orthogonal inhibitors of HIV-1 life cycle may be formulated into the non-aggregating ultrasmall NP which are highly efficient against NNRTI-resistant HIV-1 variant.
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, PK/PD data, Review, Journal: Effects of a Nutritional Protein-Rich Drink on the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide, and Tenofovir Compared With a Standard Meal in Healthy Japanese Male Subjects. (Pubmed Central) - Mar 29, 2019
The mean AUCinf and Cmax of COBI, FTC, TAF, and TFV were comparable regardless of meal intake or meal types. Although the package insert of the EVG/COBI/FTC/TAF STR states that the medication is recommended to be taken with food, this study provides an additional insight into HIV-1-infected patients that a light meal like a nutritional protein-rich drink can be an alternative to a standard meal.
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: A review on quinoline derived scaffolds as Anti-HIV Agents. (Pubmed Central) - Mar 28, 2019
Though, many more classes of different drugs that act as anti-HIV have been identified, some of which are under clinical trials, but the recent serious focus is still laid on quinoline-compounds and its analogues. In this review, we have covered all the quinoline-based derivatives that inhibit various targets and are potential anti-HIV agents in various phases of the drug discovery.
- | Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Prevalence of Human Immunodeficiency Virus-1 Integrase Strand Transfer Inhibitor Resistance in British Columbia, Canada Between 2009 and 2016: A Longitudinal Analysis. (Pubmed Central) - Mar 22, 2019
Integrase strand transfer inhibitor resistance mutations increased at integrase codons 66, 97, 140, 148, 155, and 263. The prevalence of INSTI resistance remains low compared with PI and RT resistance in ART-treated populations but is expanding with increased INSTI use.
- | Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion date, Trial suspension, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Jan 14, 2019
P=N/A, N=400, Suspended, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
The prevalence of INSTI resistance remains low compared with PI and RT resistance in ART-treated populations but is expanding with increased INSTI use. Trial completion date: Feb 2020 --> Jun 2020 | Not yet recruiting --> Suspended
- | Trial completion: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Dec 4, 2018
P3, N=224, Completed, Sponsor: University Hospital, Tours
Trial completion date: Feb 2020 --> Jun 2020 | Not yet recruiting --> Suspended Active, not recruiting --> Completed
- | Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Effects of Antiretroviral Therapy on Immune Function and Arterial Inflammation in Treatment-Naive Patients With Human Immunodeficiency Virus Infection. (Pubmed Central) - Oct 11, 2018
Newly initiated combined ART in treatment-naive individuals with HIV infection had discordant effects to restore immune function without reducing arterial inflammation. Complementary strategies to reduce arterial inflammation among ART-treated HIV-infected individuals may be needed.
- | Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial initiation date, Trial primary completion date, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Aug 9, 2018
P=N/A, N=400, Not yet recruiting, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Complementary strategies to reduce arterial inflammation among ART-treated HIV-infected individuals may be needed. Trial primary completion date: Feb 2018 --> Oct 2018 | Initiation date: Feb 2018 --> Oct 2018
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial termination: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Jul 11, 2018
P2/3, N=31, Terminated, Sponsor: Gilead Sciences
Trial primary completion date: Feb 2018 --> Oct 2018 | Initiation date: Feb 2018 --> Oct 2018 Completed --> Terminated
- | Trial primary completion date: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - May 2, 2018
P4, N=1786, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Completed --> Terminated Trial primary completion date: Mar 2018 --> Jun 2019
- |||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Trial primary completion date, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Mar 3, 2018
P3, N=673, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Mar 2018 --> Jun 2019 Trial primary completion date: Feb 2018 --> Feb 2018
- | Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial initiation date, Trial primary completion date, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Feb 14, 2018
P=N/A, N=400, Not yet recruiting, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Trial primary completion date: Feb 2018 --> Feb 2018 Initiation date: Sep 2016 --> Feb 2018 | Trial primary completion date: Mar 2017 --> Feb 2018
- || Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Nov 13, 2017
P2/3, N=31, Completed, Sponsor: Gilead Sciences
Initiation date: Sep 2016 --> Feb 2018 | Trial primary completion date: Mar 2017 --> Feb 2018 Active, not recruiting --> Completed
- | Trial primary completion date: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - Oct 7, 2017
P4, N=1786, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Trial primary completion date: Jun 2019 --> Mar 2018
- | Enrollment closed: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Oct 6, 2017
P3, N=224, Active, not recruiting, Sponsor: University Hospital, Tours
Trial primary completion date: Jun 2019 --> Mar 2018 Recruiting --> Active, not recruiting
- | Trial primary completion date: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - Apr 7, 2017
P4, N=1786, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting Trial primary completion date: Jun 2018 --> Jun 2019
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial primary completion date: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Mar 30, 2017
P2/3, N=31, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Jun 2018 --> Jun 2019 Trial primary completion date: Feb 2017 --> Jun 2017
- ||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Enrollment closed, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Mar 10, 2017
P3, N=660, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Feb 2017 --> Jun 2017 Recruiting --> Active, not recruiting
- Trial primary completion date: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Jan 4, 2017
P3, N=250, Recruiting, Sponsor: University Hospital, Tours
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Aug 2017
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment change, Trial primary completion date: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Nov 21, 2016
P2/3, N=31, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Dec 2016 --> Aug 2017 N=90 --> 31 | Trial primary completion date: Jul 2016 --> Feb 2017
- Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
New trial, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Aug 28, 2016
P=N/A, N=400, Not yet recruiting, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
- | Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion, Trial primary completion date: SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers (clinicaltrials.gov) - Aug 15, 2016
P1, N=17, Completed, Sponsor: St Stephens Aids Trust
N=90 --> 31 | Trial primary completion date: Jul 2016 --> Feb 2017 Recruiting --> Completed | Trial primary completion date: May 2015 --> Jan 2015
- |||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Trial primary completion date, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Jul 19, 2016
P3, N=660, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Completed | Trial primary completion date: May 2015 --> Jan 2015 Trial primary completion date: Mar 2017 --> Jan 2018
- ||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment closed: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - May 13, 2016
P2/3, N=90, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Mar 2017 --> Jan 2018 Recruiting --> Active, not recruiting
- Enrollment change: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - Feb 29, 2016
P4, N=1786, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting N=1300 --> 1786
- |||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Enrollment open, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Jun 20, 2015
P3, N=660, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=1300 --> 1786 Not yet recruiting --> Recruiting
- |||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Trial primary completion date, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Jun 11, 2015
P3, N=660, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2017 --> Mar 2017
- ||||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion: Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir (clinicaltrials.gov) - May 26, 2015
P3, N=724, Completed, Sponsor: Gilead Sciences
Trial primary completion date: Jun 2017 --> Mar 2017 Active, not recruiting --> Completed
- Trial primary completion date: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - Apr 28, 2015
P4, N=1300, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Trial primary completion date: May 2016 --> Jun 2018
- |||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion, Combination therapy: Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection (clinicaltrials.gov) - Apr 17, 2015
P2, N=192, Completed, Sponsor: Gilead Sciences
Trial primary completion date: May 2016 --> Jun 2018 Active, not recruiting --> Completed
- |||||||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
New P3 trial, Combination therapy: DRIVE-SHIFT: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (clinicaltrials.gov) - Mar 26, 2015
P3, N=660, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Enrollment open: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Feb 19, 2015
P3, N=250, Recruiting, Sponsor: University Hospital, Tours
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment change, Trial primary completion date, Combination therapy: Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection (clinicaltrials.gov) - Jan 22, 2015
P2, N=192, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting N=122 --> 192 | Trial primary completion date: Jan 2015 --> Apr 2015
- || Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial primary completion date, Combination therapy: Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection (clinicaltrials.gov) - Dec 6, 2014
P2, N=122, Active, not recruiting, Sponsor: Gilead Sciences
N=122 --> 192 | Trial primary completion date: Jan 2015 --> Apr 2015 Trial primary completion date: Oct 2014 --> Jan 2015
- || New P3 trial: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Nov 28, 2014
P3, N=250, Not yet recruiting, Sponsor: University Hospital, Tours
- Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment open, Trial primary completion date: SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers (clinicaltrials.gov) - Nov 5, 2014
P1, N=16, Recruiting, Sponsor: St Stephens Aids Trust
Trial primary completion date: Oct 2014 --> Jan 2015 Not yet recruiting --> Recruiting | Trial primary completion date: Nov 2014 --> May 2015
- | Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
New P1 trial: SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers (clinicaltrials.gov) - Aug 19, 2014
P1, N=16, Not yet recruiting, Sponsor: St Stephens Aids Trust
- Trial primary completion date: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - May 5, 2014
P4, N=1300, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting | Trial primary completion date: Nov 2014 --> May 2015 Trial primary completion date: May 2014 --> May 2016
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment change: Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) (clinicaltrials.gov) - Jan 15, 2014
P3, N=214, Terminated, Sponsor: Gilead Sciences
Trial primary completion date: May 2014 --> May 2016 N=700 --> 214
- || Vitekta (elvitegravir) / Japan Tobacco, Gilead
New P2/3 trial: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Aug 13, 2013
P2/3, N=86, Recruiting, Sponsor: Gilead Sciences
- | Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment open: Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (clinicaltrials.gov) - Aug 12, 2013
P2/3, N=86, Recruiting, Sponsor: Gilead Sciences
N=700 --> 214 Not yet recruiting --> Recruiting
- Enrollment change: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy (clinicaltrials.gov) - Feb 11, 2013
P4, N=1300, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting N=800 --> 1300