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12 Diseases |  |
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4 Trials |  |
242 News |  |
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- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: EMERALD: Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants (clinicaltrials.gov) - Jun 17, 2020
P3, N=1149, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Jun 2020 --> Sep 2020
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Clinical, P3 data, Journal: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study. (Pubmed Central) - May 29, 2020
Improvements in eGFR and stable bone mineral density were observed with D/C/F/TAF overall, and results were generally consistent across subgroups. For treatment-naïve patients in AMBER, initiating therapy with the D/C/F/TAF single-tablet regimen was an effective and well-tolerated option, regardless of demographic or clinical characteristics.
- |||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
New P4 trial: Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza (clinicaltrials.gov) - May 13, 2020
P4, N=100, Not yet recruiting, Sponsor: The Crofoot Research Center, Inc.
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, ritonavir / Generic mfg.
Clinical, P3 data, Journal: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. (Pubmed Central) - May 7, 2020
P3
Registered 21 October 2014. https://clinicaltrials.gov/ct2/show/NCT02269917.
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial primary completion date: DIAMANTE: An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate (clinicaltrials.gov) - Apr 27, 2020
P=N/A, N=246, Active, not recruiting, Sponsor: Janssen-Cilag S.p.A.
https://clinicaltrials.gov/ct2/show/NCT02269917. Trial primary completion date: Mar 2020 --> Jul 2020
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion, Trial completion date, Trial primary completion date: Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets (clinicaltrials.gov) - Mar 24, 2020
P1, N=25, Completed, Sponsor: Janssen Pharmaceutica N.V., Belgium
Trial primary completion date: Mar 2020 --> Jul 2020 Recruiting --> Completed | Trial completion date: Jun 2020 --> Mar 2020 | Trial primary completion date: Jun 2020 --> Mar 2020
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, tenofovir disoproxil fumarate / Generic mfg.
[VIRTUAL] USE OF D/C/F/TAF WITH NEUROLOGIC/PSYCHIATRIC COMORBIDITIES: AMBER SUBGROUP ANALYSIS ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_1211;
P3
In AMBER, the presence of NPCs did not preclude virologic response in either treatment arm. Patients with NPCs were not at added risk of discontinuing due to AEs and did not experience a higher incidence of neurologic or psychiatric AEs related to D/C/F/TAF.
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial completion date, Trial primary completion date: DETOX: A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (clinicaltrials.gov) - Feb 5, 2020
P4, N=110, Recruiting, Sponsor: Fundacion SEIMC-GESIDA
Patients with NPCs were not at added risk of discontinuing due to AEs and did not experience a higher incidence of neurologic or psychiatric AEs related to D/C/F/TAF. Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2020
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Enrollment open: A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (clinicaltrials.gov) - Feb 5, 2020
P1, N=32, Recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2020 Not yet recruiting --> Recruiting
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
New P4 trial, Adherence: Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita) (clinicaltrials.gov) - Jan 27, 2020
P4, N=30, Not yet recruiting, Sponsor: Midland Research Group, Inc.
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
New P1 trial: A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (clinicaltrials.gov) - Jan 22, 2020
P1, N=32, Not yet recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Tivicay (dolutegravir) / ViiV Healthcare
New P4 trial: P25-INACTION: Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI). (clinicaltrials.gov) - Jan 13, 2020
P4, N=112, Recruiting, Sponsor: ADRIANO LAZZARIN, MD
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
10 yrs, Symtuza is my new 1 a day. Eat well, live better, DANCE more. Cheers (Twitter) - Dec 5, 2019
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Enrollment closed: DIAMANTE: An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate (clinicaltrials.gov) - Nov 25, 2019
P=N/A, N=246, Active, not recruiting, Sponsor: Janssen-Cilag S.p.A.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | Prezcobix (darunavir/cobicistat) / Gilead, J&J, Vemlidy (tenofovir alafenamide) / Gilead
Journal: Rapid Initiation of Antiretroviral Therapy after HIV Diagnosis. (Pubmed Central) - Nov 22, 2019
At this time, the coformulation of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (Symtuza®) is the only regimen that has been evaluated in a Phase 3 trial as "test-and-treat" strategy. Results at 48 weeks in the DIAMOND study are reassuring, as more than 90% of individuals achieve undetectable viremia.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Prevalence of archived HIV-1 DNA resistance-associated mutations (RAMs) and their lack of effect on virologic outcome at week 96 in antiretroviral treatment (ART)-experienced, virologically suppressed patients receiving the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in the EMERALD phase III trial (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1706;
P3
Results at 48 weeks in the DIAMOND study are reassuring, as more than 90% of individuals achieve undetectable viremia. In EMERALD, in ART-experienced, virologically-suppressed patients, baseline archived darunavir, emtricitabine and tenofovir RAMs had no effect on virologic response/failure rates through 96 weeks, confirming the efficacy and high genetic barrier of D/C/F/TAF.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in patients with human immunodeficiency virus (HIV)-1 infection: age, race/ethnicity, and gender subgroup analyses from the DIAMOND study (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1699;
P3
D/C/F/TAF resulted in high virologic response rates across a variety of baseline demographics. Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Prevalence of archived HIV-1 DNA resistance-associated mutations (RAMs) and their lack of effect on virologic outcome at week 96 in antiretroviral treatment (ART)-experienced, virologically suppressed patients receiving the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in the EMERALD phase III trial (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_896;
P3
Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation. In EMERALD, in ART-experienced, virologically-suppressed patients, baseline archived darunavir, emtricitabine and tenofovir RAMs had no effect on virologic response/failure rates through 96 weeks, confirming the efficacy and high genetic barrier of D/C/F/TAF.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in patients with human immunodeficiency virus (HIV)-1 infection: age, race/ethnicity, and gender subgroup analyses from the DIAMOND study (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_889;
P3
D/C/F/TAF resulted in high virologic response rates across a variety of baseline demographics. Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Prevalence of archived HIV-1 DNA resistance-associated mutations (RAMs) and their lack of effect on virologic outcome at week 96 in antiretroviral treatment (ART)-experienced, virologically suppressed patients receiving the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in the EMERALD phase III trial (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_148;
P3
Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation. In EMERALD, in ART-experienced, virologically-suppressed patients, baseline archived darunavir, emtricitabine and tenofovir RAMs had no effect on virologic response/failure rates through 96 weeks, confirming the efficacy and high genetic barrier of D/C/F/TAF.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in patients with human immunodeficiency virus (HIV)-1 infection: age, race/ethnicity, and gender subgroup analyses from the DIAMOND study (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_141;
P3
D/C/F/TAF resulted in high virologic response rates across a variety of baseline demographics. Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation.
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Enrollment open: Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets (clinicaltrials.gov) - Nov 11, 2019
P1, N=24, Recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
Treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred antiretroviral therapy option for rapid initiation. Not yet recruiting --> Recruiting
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Clinical, P3 data, Journal: A week 48 randomized phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. (Pubmed Central) - Oct 25, 2019
P3
D/C/F/TAF achieved a high virologic suppression rate (91.4%) and was noninferior to darunavir/cobicistat with F/TDF. D/C/F/TAF also demonstrated the bone and renal safety advantages of TAF in combination with darunavir/cobicistat.
- Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
High Rates of Virologic Suppression Achieved in HIV-1–Infected Adults Rapidly Starting Antiretroviral Therapy (ART) With the Single-Tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg Regardless of Baseline Disease Characteristics: Week 48 Subgroup Analyses From the Phase 3 DIAMOND Trial (144 ABC) - Sep 12, 2019 - Abstract #IDWeek2019IDWeek_687;
P3
Conclusion : In the first phase 3 study of an STR in a rapid initiation model, no patients rapidly starting D/C/F/TAF discontinued therapy due to lack of efficacy or had PDVF through 48 weeks. High rates of virologic suppression were achieved and maintained with a variety of baseline characteristics, and treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred ART option for patients rapidly starting treatment.
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion, Trial primary completion date: DIAMOND: A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (clinicaltrials.gov) - Sep 11, 2019
P3, N=109, Completed, Sponsor: Janssen Scientific Affairs, LLC
High rates of virologic suppression were achieved and maintained with a variety of baseline characteristics, and treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred ART option for patients rapidly starting treatment. Active, not recruiting --> Completed | Trial primary completion date: Jul 2019 --> Jan 2019
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial completion date, Trial primary completion date: DETOX: A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (clinicaltrials.gov) - Aug 28, 2019
P4, N=110, Recruiting, Sponsor: Fundacion SEIMC-GESIDA
Active, not recruiting --> Completed | Trial primary completion date: Jul 2019 --> Jan 2019 Trial completion date: Jul 2019 --> Dec 2019 | Trial primary completion date: Jul 2019 --> Dec 2019
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezcobix (darunavir/cobicistat) / Gilead, J&J
Journal: Pharmacology of Symtuza (DRV/c/FTC/TAF). (Pubmed Central) - Aug 1, 2019
This combination is active against a wide variety of HIV strains and, in turn, avoids bone and renal toxicity associated with the use of tenofovir disoproxil fumarate, combining efficacy, convenience, tolerability and high genetic barrier...Although, as in any boosted combination, possible interactions with concomitant medication should be borne in mind, cobici-stat inhibits cytochrome P-450 more selectively and has no inducing effect, so it has a more predictable interaction profile than ritonavir. Supplement information: This article is part of a supplement entitled "Co-formulated cobicistat-boosted darunavir, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection", which is sponsored by Janssen.
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezista (darunavir) / J&J
Clinical, Journal: Symtuza (DRV/c/FTC/TAF) in the management of treatment-naive HIV-patients. (Pubmed Central) - Aug 1, 2019
It therefore represents a very good regimen for naive patients, in particular those at risk of poor adherence, and those with low potential risk for drug-drug interactions. Supplement information: This article is part of a supplement entitled "Co-formulated cobicistat-boosted darunavir, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection", which is sponsored by Janssen.
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezcobix (darunavir/cobicistat) / Gilead, J&J
Clinical, Journal: Symtuza (DRV/c/FTC/TAF) in the management of previously treated patients. (Pubmed Central) - Aug 1, 2019
The EMERALD clinical trial demonstrates the non-inferiority of the switch to Symtuza, a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide in a single tablet, in patients with sustained viral suppression. Supplement information: This article is part of a supplement entitled "Co-formulated cobicistat-boosted darunavir, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection", which is sponsored by Janssen.
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezista (darunavir) / J&J, Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Journal: Symtuza in clinical practice. (Pubmed Central) - Aug 1, 2019
The drug is especially useful in patients with suspected poor adherence, those requiring rapid treatment initiation because of late presentation or opportunistic infection, patients with limitations for other alternatives, and those with a history of previous failure or resistance to other classes of drugs. Supplement information: This article is part of a supplement entitled "Co-formulated cobicistat-boosted darunavir, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection", which is sponsored by Janssen.
- || Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
New P1 trial: Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets (clinicaltrials.gov) - Jul 4, 2019
P1, N=24, Not yet recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: AMBER: A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects (clinicaltrials.gov) - Jun 26, 2019
P3, N=725, Active, not recruiting, Sponsor: Janssen Sciences Ireland UC
Supplement information: This article is part of a supplement entitled "Co-formulated cobicistat-boosted darunavir, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection", which is sponsored by Janssen. Trial completion date: Dec 2019 --> Jun 2020
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: DIAMANTE: An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate (clinicaltrials.gov) - May 15, 2019
P=N/A, N=250, Recruiting, Sponsor: Janssen-Cilag S.p.A.
Trial completion date: Dec 2019 --> Jun 2020 Trial completion date: Mar 2020 --> Jun 2020
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Enrollment open, Trial completion date, Trial primary completion date: DETOX: A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (clinicaltrials.gov) - Apr 9, 2019
P4, N=110, Recruiting, Sponsor: Fundacion SEIMC-GESIDA
Trial completion date: Mar 2020 --> Jun 2020 Not yet recruiting --> Recruiting | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Feb 2019 --> Jul 2019
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Clinical, Review, Journal: Darunavir-cobicistat-emtricitabine-tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era. (Pubmed Central) - Mar 28, 2019
Bone and central nervous system safety profiles were found to be good in randomized clinical trials of both experienced and naïve patients. The efficacy and safety of Drv/Cobi/FTC/Taf are comparable to other drug regimens recommended for HIV treatment.
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial primary completion date: DIAMOND: A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (clinicaltrials.gov) - Mar 28, 2019
P3, N=109, Active, not recruiting, Sponsor: Janssen Scientific Affairs, LLC
The efficacy and safety of Drv/Cobi/FTC/Taf are comparable to other drug regimens recommended for HIV treatment. Trial primary completion date: Dec 2018 --> Jul 2019
- |||||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open, Trial completion date, Trial primary completion date, Metastases: The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) - Mar 15, 2019
P3, N=440, Recruiting, Sponsor: NEAT ID Foundation
Trial primary completion date: Dec 2018 --> Jul 2019 Not yet recruiting --> Recruiting | Trial completion date: Jul 2022 --> Dec 2021 | Trial primary completion date: Jan 2022 --> Jun 2021
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: AMBER: A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects (clinicaltrials.gov) - Mar 4, 2019
P3, N=725, Active, not recruiting, Sponsor: Janssen Sciences Ireland UC
Not yet recruiting --> Recruiting | Trial completion date: Jul 2022 --> Dec 2021 | Trial primary completion date: Jan 2022 --> Jun 2021 Trial completion date: Apr 2020 --> Dec 2019
- |||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
New P4 trial: DETOX Study Estudio DETOX (EUDRACT) - Dec 5, 2018
P4, N=110, Ongoing, Sponsor: Fundación SEIMC-GESIDA
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
New P4 trial: Study to compare two treatments in patients who have never taken HIV medication randomized in different centers in Spain. (The Symtri study) Estudio para comparar dos tratamientos en pacientes que nunca han tomado medicaci (EUDRACT) - Dec 4, 2018
P4, N=316, Ongoing, Sponsor: Spanish HIV/AIDS Research Network
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: DIAMOND: A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (clinicaltrials.gov) - Oct 10, 2018
P3, N=109, Active, not recruiting, Sponsor: Janssen Scientific Affairs, LLC
Trial completion date: Apr 2020 --> Dec 2019 Trial completion date: Dec 2018 --> Jul 2019
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
New P3 trial, Metastases: The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) - Oct 3, 2018
P3, N=440, Not yet recruiting, Sponsor: NEAT ID Foundation
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
New P4 trial: DETOX: A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (clinicaltrials.gov) - Sep 26, 2018
P4, N=110, Not yet recruiting, Sponsor: Fundacion SEIMC-GESIDA
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
New trial: DIAMANTE: An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate (clinicaltrials.gov) - Aug 21, 2018
P=N/A, N=250, Recruiting, Sponsor: Janssen-Cilag S.p.A.
- | Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date: EMERALD: Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants (clinicaltrials.gov) - Jul 26, 2018
P3, N=1153, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Dec 2018 --> Jul 2019 Trial completion date: Sep 2019 --> Mar 2020
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date, IO biomarker: EMERALD: Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants (clinicaltrials.gov) - Apr 26, 2018
P3, N=1154, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Sep 2019 --> Mar 2020 Trial completion date: Mar 2019 --> Sep 2019
- ||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial completion date, IO biomarker: EMERALD: Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants (clinicaltrials.gov) - Mar 3, 2018
P3, N=1153, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Mar 2019 --> Sep 2019 Trial completion date: Oct 2019 --> Mar 2019
- ||||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Enrollment closed, Trial completion date, Trial primary completion date, IO biomarker: DIAMOND: A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (clinicaltrials.gov) - Feb 15, 2018
P3, N=100, Active, not recruiting, Sponsor: Janssen Scientific Affairs, LLC
Trial completion date: Oct 2019 --> Mar 2019 Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Dec 2018 | Trial primary completion date: Jan 2019 --> Dec 2018
- |||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial primary completion date, IO biomarker: AMBER: A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects (clinicaltrials.gov) - Oct 10, 2017
P3, N=725, Active, not recruiting, Sponsor: Janssen Sciences Ireland UC
Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Dec 2018 | Trial primary completion date: Jan 2019 --> Dec 2018 Trial primary completion date: Dec 2018 --> Mar 2017
- |||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
Trial primary completion date, IO biomarker: EMERALD: Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants (clinicaltrials.gov) - Oct 10, 2017
P3, N=1153, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial primary completion date: Dec 2018 --> Mar 2017 Trial primary completion date: Dec 2018 --> Feb 2017