A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 02 Jul 2018
At a glance
- Drugs Dolutegravir (Primary) ; Emtricitabine/tenofovir; Lamivudine
- Indications HIV-1 infections
- Focus Registrational; Therapeutic Use
- Acronyms Gemini 1
- Sponsors ViiV Healthcare
- 02 Jul 2018 According to Takeda Pharma Media release, based on the data from the CCT-101 Study and GEMINI 1 company has obtained a New Drug Application Approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Entyvio (generic name: vedolizumab, development code: MLN0002) for the treatment of patients with moderately to severely active ulcerative colitis (UC) in Japan.
- 14 Jun 2018 Primary endpoint has been met. (Percentage of subjects with plasma HIV 1 RNA 50 copies/milliliter at Week 48)
- 08 Mar 2018 Planned End Date changed from 3 Feb 2024 to 3 Mar 2020.