Switch Study of Dolutegravir + Rilpivirine in HIV infected adults-636
Research type
Research Study
Full title
A Phase III, randomised, multicentre, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed.
IRAS ID
169928
Contact name
Frank Post
Contact email
Eudract number
2014-005147-40
Duration of Study in the UK
4 years, 3 months, 23 days
Research summary
This study is looking at the safety and efficacy of switching to dolutegravir (DTG) plus rilpivirine (RPV) from current antiretroviral treatment in HIV-1-infected adults who are virologically suppressed over 148 weeks.
Dolutegravir is an integrase inhibitor which has recently be made available on prescription in the UK. It works by blocking the action of a specific enzyme which is involved in several key steps in the HIV life cycle. It is taken once daily.
This study will include approximately 476 participants in about 14 countries globally and is sponsored by ViiV Healthcare.
Eligible HIV-infected participants will need to be aged 18 years or over and should have a viral load of <50c/ml. They should have been on uninterrupted anti-retroviral therapy for at least 6 months and be on their 1st or 2nd regimen.
Following their first visit, participants will have a screening period of up to 28 days to ensure eligibility prior to starting study treatment. Participants will then be randomly assigned to either DTG+RPV or to continue on their current treatment. They will know which treatment they are receiving. Participants will have visits at weeks 2, 4, 8 and 12 then every 12 weeks until week 48. At week 52 participants randomised to continue on current treatment will switch to DTG+RPV. All participants will then continue on DTG + RPV, having 12-weekly visits until week 148. Assessments will include Treatment Satisfaction questionnaires, physical examinations, an ECG and blood samples.
All participants who complete 148 weeks of treatment will continue to have access to DTG+RPV until either it is locally approved and commercially available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated. Participants will continue having 12-weekly visits during this time.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0853
Date of REC Opinion
28 May 2015
REC opinion
Favourable Opinion