- |||||||||| 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, Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Apr 2019
- |||||||||| lamivudine / generics
Characterization of Patient Pill Preferences from a Prospective Placebo vs. Placebo Ease of Swallowability Study () - Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2916; When given free response, pills having a smooth coating was reinforced by 10 of the 25 (40%) participants who commented.Conclusion : Patient preferences for medications are varied and nuanced, but carry implications on patients self-reported likelihood to remain adherent to a regimen. Care should be taken in a clinical setting, such as HIV, to take pill characteristics into account when selecting antiretroviral regimens for patients.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection. (Pubmed Central) - Aug 3, 2019 Bictegravir/emtricitabine/tenofovir AF is generally well tolerated, requires no prior HLA-B*5701 testing (making it more suitable for 'rapid start' treatment), fulfils the antiretroviral regimen requirement for patients with hepatitis B virus (HBV) co-infection (i.e. contains tenofovir AF and emtricitabine, both of which are active against HBV) and can be used in renally impaired patients with creatinine clearance (CR) ≥ 30 mL/min. Thus, although cost-effectiveness analyses would be beneficial, current data indicate that bictegravir/emtricitabine/tenofovir AF is a convenient initial and subsequent treatment option for adults with HIV-1 infection, including those co-infected with HBV, and provides the first non-pharmacologically boosted, INSTI-based, triple-combination STR suitable for patients with CR 30-50 mL/min.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (clinicaltrials.gov) - Jul 30, 2019 P3, N=631, Active, not recruiting, Thus, although cost-effectiveness analyses would be beneficial, current data indicate that bictegravir/emtricitabine/tenofovir AF is a convenient initial and subsequent treatment option for adults with HIV-1 infection, including those co-infected with HBV, and provides the first non-pharmacologically boosted, INSTI-based, triple-combination STR suitable for patients with CR 30-50 mL/min. Trial completion date: Aug 2021 --> May 2021
- |||||||||| dolutegravir + abacavir sulphate +lamivudine / GSK, Epivir (lamivudine) / ViiV Healthcare, Ziagen (abacavir) / ViiV Healthcare
Clinical, Journal: Case report of Triumeq (abacavir/dolutegravir/lamivudine) associated rhabdomyolysis in a human immunodeficiency virus (HIV) infected patient. (Pubmed Central) - May 29, 2019 Our data suggest an improvement in lipid profile and TG/HDL ratio in pretreated HIV-1-infected patients who switched to DTG/ABC/3TC over 48 weeks, especially in those previously receiving a bPI-based regimen. This case aims to recognize rhabdomyolysis as a rare, but possible adverse effect associated with the use of Triumeq for HIV-infected patients and therefore clinicians prescribing this combination should be aware of this potential side effect and counsel their patients accordingly.
- |||||||||| 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, Monitoring the medical and cost impacts of de-simplification strategies seems warranted. Recruiting --> Active, not recruiting | N=64 --> 39 | Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Sep 2018 --> Jun 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 4, 2018 P4, N=110, Ongoing,
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial termination, Monotherapy: MONCAY: Study to Evaluate the Efficacy of MONotherapy of TiviCAY (clinicaltrials.gov) - Nov 13, 2018 P3, N=158, Terminated, Trial completion date: Jul 2019 --> Jun 2020 Completed --> Terminated; 5 patients on tivicay had virological failure
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial completion, Monotherapy: MONCAY: Study to Evaluate the Efficacy of MONotherapy of TiviCAY (clinicaltrials.gov) - Sep 24, 2018 P3, N=158, Completed, Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2018 --> Dec 2018 Recruiting --> Completed
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial completion, Trial completion date, Trial initiation date: SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over (clinicaltrials.gov) - Feb 28, 2018 P4, N=40, Completed, Trial completion date: Jan 2019 --> Jul 2021 | Trial primary completion date: Jan 2018 --> Jul 2021 Active, not recruiting --> Completed | Trial completion date: Jul 2017 --> Jul 2017 | Initiation date: Jul 2015 --> Aug 2015
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Trial primary completion date, Monotherapy: MONCAY: Study to Evaluate the Efficacy of MONotherapy of TiviCAY (clinicaltrials.gov) - Jan 17, 2018 P3, N=160, Recruiting, Active, not recruiting --> Completed | Trial completion date: Jul 2017 --> Jul 2017 | Initiation date: Jul 2015 --> Aug 2015 Trial primary completion date: Jun 2018 --> Jun 2017
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Enrollment open, Enrollment change, Trial primary completion date: Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 (clinicaltrials.gov) - Aug 10, 2017 P3, N=80, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | N=40 --> 80 | Trial primary completion date: Apr 2019 --> Dec 2023
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