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24 Diseases |  |
14 Trials |
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14 Trials |  |
566 News |  |
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- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Clinical, PK/PD data, Journal: Effects of Milk or Apple Juice Ingestion on the Pharmacokinetics of Elvitegravir and Cobicistat in Healthy Japanese Male Volunteers: A Randomized, Single-Dose, Three-Way Crossover Study. (Pubmed Central) - Oct 10, 2019
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) is specified in its package insert to be taken with food to obtain sufficient exposure of EVG...The mean C24 of EVG after milk ingestion was 620.6 ng/mL, which was more than 10-fold the protein binding-adjusted 95% inhibitory concentration. With all the above considerations, it was concluded that taking EVG/COBI/FTC/TAF with milk could be an option to maintain sufficient plasma concentrations of EVG.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: Analysis of Crushed and Whole Tablet Genvoya (clinicaltrials.gov) - Sep 29, 2019
P4, N=12, Active, not recruiting, Sponsor: Johns Hopkins University
With all the above considerations, it was concluded that taking EVG/COBI/FTC/TAF with milk could be an option to maintain sufficient plasma concentrations of EVG. Recruiting --> Active, not recruiting | Trial completion date: Sep 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Mar 2020
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Clinical, Journal, Combination therapy: Effects of antiretroviral combination therapies F/TAF, E/C/F/TAF and R/F/TAF on insulin resistance in healthy volunteers: The TAF-IR Study. (Pubmed Central) - Sep 28, 2019
Recruiting --> Active, not recruiting | Trial completion date: Sep 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Mar 2020 Short-term treatment for F/TAF, E/C/F/TAF, or R/F/TAF did not increase IR in healthy male volunteers.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial primary completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Sep 26, 2019
P2, N=150, Recruiting, Sponsor: AIDS Clinical Trials Group
Short-term treatment for F/TAF, E/C/F/TAF, or R/F/TAF did not increase IR in healthy male volunteers. Trial primary completion date: Jul 2019 --> Dec 2019
- | Tybost (cobicistat) / Gilead, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion date: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (clinicaltrials.gov) - Sep 23, 2019
P3, N=1443, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Jul 2019 --> Dec 2019 Trial completion date: Jul 2019 --> Dec 2019
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion, Enrollment change: Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities (clinicaltrials.gov) - Sep 16, 2019
P1, N=48, Completed, Sponsor: Emory University
Trial completion date: Jul 2019 --> Dec 2019 Recruiting --> Completed | N=90 --> 48
- | Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion, Trial completion date: A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study (clinicaltrials.gov) - Aug 28, 2019
P4, N=39, Completed, Sponsor: Fundacion SEIMC-GESIDA
Recruiting --> Completed | N=90 --> 48 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Apr 2019
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Enrollment change, Trial primary completion date: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection (clinicaltrials.gov) - Aug 28, 2019
P=N/A, N=275, Active, not recruiting, Sponsor: National Taiwan University Hospital
Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Apr 2019 Recruiting --> Active, not recruiting | N=200 --> 275 | Trial primary completion date: Oct 2019 --> Feb 2019
- Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Longer-Term Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically-Suppressed Adults Living With HIV and End Stage Renal Disease on Chronic Hemodialysis () - Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2902;
E/C/F/TAF was well tolerated and was associated with improved participant satisfaction. These data demonstrate that E/C/F/TAF is a safe and effective alternative to more complicated regimens in PLH on chronic HD, with the potential to improve patient satisfaction and quality of life.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion: Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (clinicaltrials.gov) - Aug 14, 2019
P3b, N=64, Completed, Sponsor: Gilead Sciences
These data demonstrate that E/C/F/TAF is a safe and effective alternative to more complicated regimens in PLH on chronic HD, with the potential to improve patient satisfaction and quality of life. Active, not recruiting --> Completed
- | Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
New P3 trial: ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - Aug 8, 2019
P3, N=360, Not yet recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Preclinical, Journal: Long-acting parenteral combination antiretroviral loaded nano-drug delivery system to treat chronic HIV-1 infection: A humanized mouse model study. (Pubmed Central) - Aug 8, 2019
...The cARV (elvitegravir+tenofovir alafenamide+emtricitabine; EVG+TAF+FTC) drugs (mimicking marketed Genvoya one-pill for HIV-treatment) were encapsulated in poly (lactic-co-glycolic acid) nanoparticles (NPs)...The present study demonstrated cARV NPs augments sustained ARV efficacy in the cHIV humanized-mouse model. Therefore, cARV NPs could be a novel delivery system to treat cHIV patients, by overcoming drawbacks of conventional cART.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (clinicaltrials.gov) - Aug 8, 2019
P2/3, N=125, Recruiting, Sponsor: Gilead Sciences
Therefore, cARV NPs could be a novel delivery system to treat cHIV patients, by overcoming drawbacks of conventional cART. Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: Jul 2020 --> Oct 2020
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
Clinical, Journal: Evaluation of Safety and Effectiveness of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch Followed by Ledipasvir/Sofosbuvir HCV Therapy in HIV-HCV Coinfection. (Pubmed Central) - Aug 2, 2019
Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: Jul 2020 --> Oct 2020 Provision of this 2-tablet daily HIV-HCV regimen is feasible, well tolerated, and safe, avoids drug-drug interactions between HIV and HCV medications, maintains HIV suppression in the absence of drug resistance, and is highly curative of HCV.
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead, Reyataz (atazanavir sulfate) / BMS
Clinical, P3 data, Journal: Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. (Pubmed Central) - Jul 16, 2019
...Objective: In Asian population requiring treatment, it is imperative to have data specific to this group, particularly as there is a general concern that Asians with lower body weight have increased risk of tenofovir disoproxil fumarate (TDF)-related renal dysfunction...Study 109 was a randomized, open-label, 96-week study conducted in virologically suppressed, ART-experienced participants, who switched to E/C/F/TAF from ritonavir/cobicistat-boosted atazanavir ATV+(RTV or COBI) + F/TDF regimens, from non-nucleoside reverse transcriptase inhibitors (NNRTI) + F/TDF regimens, or from E/C/F/TDF...Lastly, in Study 112, 91% maintained virologic suppression at week 144. There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies.
- ||| Tybost (cobicistat) / Gilead, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion date: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (clinicaltrials.gov) - Jun 18, 2019
P3, N=1443, Active, not recruiting, Sponsor: Gilead Sciences
There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies. Trial completion date: Mar 2019 --> Jul 2019
- | Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Superior Efficacy and Improved Renal and Bone Safety After Switching From a Tenofovir Disoproxil Fumarate (TDF)- to a Tenofovir Alafenamide (TAF)-based Regimen Through 96 Weeks of Treatment. (Pubmed Central) - Jun 17, 2019
P3
Trial completion date: Mar 2019 --> Jul 2019 Switching to E/C/F/TAF was associated with statistically significant efficacy and safety advantages over remaining on a standard-of-care TDF-based regimen.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
New P1 trial: Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens (clinicaltrials.gov) - Jun 5, 2019
P1, N=62, Recruiting, Sponsor: Emory University
- Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open: Analysis of Crushed and Whole Tablet Genvoya (clinicaltrials.gov) - May 16, 2019
P4, N=12, Recruiting, Sponsor: Johns Hopkins University
Switching to E/C/F/TAF was associated with statistically significant efficacy and safety advantages over remaining on a standard-of-care TDF-based regimen. Not yet recruiting --> Recruiting
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead
Clinical, Journal: A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction. (Pubmed Central) - May 15, 2019
Not yet recruiting --> Recruiting Education from an ambulatory clinic-based HIV pharmacist resulted in high rates of patient satisfaction and understanding of the switch from TDF to TAF-containing ART.
- || dolutegravir + abacavir sulphate +lamivudine / GSK, Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Dr. Sierra, pero si usted requiere de Genvoya o Triumeq lo daremos (en el país) en genérico?? Me lo están convenciendo los de la 4T?? (Twitter) - May 9, 2019
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead, Reyataz (atazanavir sulfate) / BMS
Clinical, Journal: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/Taf) in Virologically Suppressed Women. (Pubmed Central) - May 5, 2019
Education from an ambulatory clinic-based HIV pharmacist resulted in high rates of patient satisfaction and understanding of the switch from TDF to TAF-containing ART. Switching to E/C/F/TAF was noninferior to continuing ATV+RTV plus FTC/TDF in maintaining virologic suppression and was well tolerated at 48 weeks.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment change, Trial withdrawal: Antiretroviral Therapy for Acute HIV Infection (clinicaltrials.gov) - Apr 25, 2019
P=N/A, N=0, Withdrawn, Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Switching to E/C/F/TAF was noninferior to continuing ATV+RTV plus FTC/TDF in maintaining virologic suppression and was well tolerated at 48 weeks. N=100 --> 0 | Recruiting --> Withdrawn
- | Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) / Gilead
Clinical, Journal: Overdose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in an HIV-1-infected subject with attempted suicide. (Pubmed Central) - Apr 18, 2019
N=100 --> 0 | Recruiting --> Withdrawn A suicidal attempt with an E/C/F/TAF overdose in an HIV-infected patient, resulted in a favourable outcome from a renal and neuropsychiatric standpoint.
- ||| Enrollment open, Trial completion date, Trial primary completion date, Adherence: Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy (clinicaltrials.gov) - Apr 16, 2019
P4, N=100, Recruiting, Sponsor: mHealth UCSD
A suicidal attempt with an E/C/F/TAF overdose in an HIV-infected patient, resulted in a favourable outcome from a renal and neuropsychiatric standpoint. Not yet recruiting --> Recruiting | Trial completion date: Oct 2019 --> Jun 2020 | Trial primary completion date: Sep 2018 --> Jun 2020
- | Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study (clinicaltrials.gov) - Apr 9, 2019
P4, N=39, Active, not recruiting, Sponsor: Fundacion SEIMC-GESIDA
Not yet recruiting --> Recruiting | Trial completion date: Oct 2019 --> Jun 2020 | Trial primary completion date: Sep 2018 --> Jun 2020 Recruiting --> Active, not recruiting | N=64 --> 39 | Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Sep 2018 --> Jun 2019
- Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, ritonavir / Generic mfg.
Factors associated with lipid variations after switch to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in patients with well-controlled HIV infection () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_1152;
switch to E/C/F/TAF in virologically-suppressed HIV1 infected patients leads to a significant increase of both TC, LDL-C and HDL-C. Although lipid elevations were greater in patients with low baseline lipid values, the cardiovascular safety of long-term E/C/F/TAF treatment should be called into question.
- || Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis (clinicaltrials.gov) - Apr 3, 2019
P3b, N=55, Active, not recruiting, Sponsor: Gilead Sciences
Although lipid elevations were greater in patients with low baseline lipid values, the cardiovascular safety of long-term E/C/F/TAF treatment should be called into question. Trial completion date: Jul 2019 --> Oct 2019
- | 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.
- ||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
New trial: Antiretroviral Therapy for Acute HIV Infection (clinicaltrials.gov) - Mar 15, 2019
P=N/A, N=100, Recruiting, Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
- Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial initiation date: Analysis of Crushed and Whole Tablet Genvoya (clinicaltrials.gov) - Feb 21, 2019
P4, N=12, Not yet recruiting, Sponsor: Johns Hopkins University
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. Initiation date: Jan 2019 --> Apr 2019
- ||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion, Trial primary completion date, Compliance: Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis (clinicaltrials.gov) - Feb 15, 2019
P3, N=101, Completed, Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Initiation date: Jan 2019 --> Apr 2019 Enrolling by invitation --> Completed | Trial primary completion date: Mar 2018 --> Jun 2018
- | Prezista (darunavir) / J&J, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: PEP2: Body Compartment Pharmacokinetics of Anti- Retroviral Agents That May be Used for Future HIV Post- Exposure Prophylaxis. (clinicaltrials.gov) - Feb 7, 2019
P1, N=58, Recruiting, Sponsor: Emory University
Enrolling by invitation --> Completed | Trial primary completion date: Mar 2018 --> Jun 2018 Trial completion date: Jan 2019 --> Dec 2019 | Trial primary completion date: Jan 2019 --> Dec 2019
- ||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion: Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women (clinicaltrials.gov) - Jan 8, 2019
P3, N=472, Completed, Sponsor: Gilead Sciences
Trial completion date: Jan 2019 --> Dec 2019 | Trial primary completion date: Jan 2019 --> Dec 2019 Active, not recruiting --> Completed
- |||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open, Trial completion date: Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (clinicaltrials.gov) - Dec 20, 2018
P2/3, N=125, Recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Active, not recruiting --> Recruiting | Trial completion date: Dec 2021 --> Jul 2020
- |||| Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
New P4 trial: EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE. Eficacia y seguridad de Dolutegravir m (EUDRACT) - Dec 4, 2018
P4, N=100, Ongoing, Sponsor: FUNDACI
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial initiation date: Analysis of Crushed and Whole Tablet Genvoya (clinicaltrials.gov) - Nov 21, 2018
P4, N=12, Not yet recruiting, Sponsor: Johns Hopkins University
Active, not recruiting --> Recruiting | Trial completion date: Dec 2021 --> Jul 2020 Initiation date: Oct 2018 --> Jan 2019
- | Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion: WAVES: Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women (clinicaltrials.gov) - Oct 30, 2018
P3b, N=583, Completed, Sponsor: Gilead Sciences
Initiation date: Oct 2018 --> Jan 2019 Active, not recruiting --> Completed
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (clinicaltrials.gov) - Oct 30, 2018
P3b, N=64, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Trial completion date: Sep 2019 --> Jun 2019
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
New P4 trial: Analysis of Crushed and Whole Tablet Genvoya (clinicaltrials.gov) - Oct 24, 2018
P4, N=12, Not yet recruiting, Sponsor: Johns Hopkins University
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis (clinicaltrials.gov) - Oct 16, 2018
P3b, N=55, Active, not recruiting, Sponsor: Gilead Sciences
Trial completion date: Sep 2019 --> Jun 2019 Trial completion date: Aug 2018 --> Jul 2019
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
New P4 trial: GENIS: A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Na (clinicaltrials.gov) - Oct 2, 2018
P4, N=50, Recruiting, Sponsor: Fundacion SEIMC-GESIDA
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion: Open-label Safety Study of E/C/F/TAF (Genvoya (clinicaltrials.gov) - Sep 19, 2018
P3, N=252, Completed, Sponsor: Gilead Sciences
Trial completion date: Aug 2018 --> Jul 2019 Active, not recruiting --> Completed
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion date: Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults (clinicaltrials.gov) - Sep 18, 2018
P3, N=872, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Trial completion date: Jun 2018 --> Sep 2018
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Enrollment change: Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (clinicaltrials.gov) - Sep 6, 2018
P3b, N=64, Active, not recruiting, Sponsor: Gilead Sciences
Trial completion date: Jun 2018 --> Sep 2018 Recruiting --> Active, not recruiting | N=100 --> 64
- | Tybost (cobicistat) / Gilead, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion date: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (clinicaltrials.gov) - Aug 31, 2018
P3, N=1443, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | N=100 --> 64 Trial completion date: Jun 2018 --> Jan 2019
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial primary completion date: Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (clinicaltrials.gov) - Aug 27, 2018
P2/3, N=100, Active, not recruiting, Sponsor: Gilead Sciences
Trial completion date: Jun 2018 --> Jan 2019 Trial primary completion date: Jul 2018 --> Jul 2020
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Jul 31, 2018
P2, N=150, Recruiting, Sponsor: AIDS Clinical Trials Group
Trial primary completion date: Jul 2018 --> Jul 2020 Trial completion date: Dec 2019 --> Jun 2020
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection (clinicaltrials.gov) - Jul 20, 2018
P=N/A, N=200, Recruiting, Sponsor: National Taiwan University Hospital
Trial completion date: Dec 2019 --> Jun 2020 Not yet recruiting --> Recruiting
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
New P4 trial: Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy (clinicaltrials.gov) - Jul 15, 2018
P4, N=25, Recruiting, Sponsor: Saskatchewan Health Authority - Regina Area