WHO ICTRP trial
A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus…
EUCTR2015-004418-95-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-004418-95-DE |
|---|---|
| Public title | A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected patients that have not been treated yet. |
| Scientific title | 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 HIV-1-infected treatment-naïve adults - Gemini I |
| Primary sponsor | ViiV Healthcare UK Limited |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Romania;Australia;South Africa;Germany;Netherlands;Korea, Republic of |
| Conditions | Human Immunodeficiency Virus-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02] |
| Interventions | Trade Name: Tivicay® Product Name: Dolutegravir,DTG Product Code: GSK1349572 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DOLUTEGRAVIR CAS Number: 1051375-19-9 Current Sponsor code: GSK1349572 Other descriptive name… |
| Registration date | May 20, 2016 |
| Target size | 700 |
| Secondary IDs | 204861 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: