Study to compare 2-drug with 3-drug regimen in patients with HIV-1
Research type
Research Study
Full 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
IRAS ID
204396
Contact name
Amanda Clarke
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Eudract number
2015-004418-95
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Summary of Research
This is a Phase 3, multicentre study sponsored by ViiV Healthcare and GSK.
The purpose of this study is to determine how well an antiretroviral (ARV) regimen of two previously approved medicines, dolutegravir (DTG) plus lamivudine (3TC), works compared to the three-drug regimen of DTG plus the combination of tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC), another previously approved combination medicine, in the treatment of human immunodeficiency virus (HIV) infected adults. The two drug regimen of DTG plus 3TC is considered experimental and is not yet approved to treat patients with HIV.
The study will enrol approximately 700 HIV-1 infected, treatment-naïve participants. Participants will be enrolled in a 1:1 ratio to receive a two-drug regimen of DTG plus 3TC once daily or DTG plus the Fixed Dose Combination (FDC) tablet of TDF/FTC once daily until Week 148.
The study will consist of a 28-day Screening Phase (may be extended to 35 days), a Double-blind Randomised Phase (Day 1 to Week 96), an Open-label Randomised Phase (Week 96 -Week 148) and a Continuation Phase (post Week 148). The study will consist of up to 20 visits with an expected duration of participation of about 3 years (153 weeks).
This study involves procedures including physical examinations, questionnaires,ECG, blood and urine tests.
At the Week 148 visit the main study will end. If participants are taking DTG plus TDF/FTC, they will complete the study at Week 148. If participants have received DTG plus 3TC during the study, they may choose to continue receiving DTG plus 3TC. If they decide to continue they will return for visits every 12 weeks until both DTG and 3TC become available and the combination of DTG plus 3TC is approved, the drug no longer works for them, or ViiV Healthcare/GSK are no longer developing the DTG/3TC combination medicine.
Summary of Results
https://www.trialsummaries.com/Study/StudyDetails?id=3676&tenant=MT_VIV_9011
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1112
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion