Study of Intramuscular Cabotegravir + Rilpivirine in ART naive adults
Research type
Research Study
Full title
A Phase III, Randomised, Multicentre, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
IRAS ID
208340
Contact name
Sarah Pett
Contact email
Sponsor organisation
ViiV Healthcare
Eudract number
2016-001646-25
Duration of Study in the UK
3 years, 11 months, 7 days
Research summary
This study is looking at the safety and efficacy of injectable Cabotegravir and Rilpivirine compared to a single tablet regimen in HIV-1-infected adults who have not been on HIV medication before.
Cabotegravir and Rilpivirine work by blocking the ability of the HIV virus to make more copies of itself. They can both be delivered by a long-acting injection every 4 weeks.
This study will include approximately 620 participants in 11 countries with about 33 participants in the UK and is sponsored by ViiV Healthcare.
Eligible HIV-infected adults will be 18 years or older and should have a viral load of >1000 c/ml. They should not have taken HIV medication before.
Following their first visit, participants will have a screening period of up to 35 days to ensure study eligibility. Then participants will start treatment on Abacavir/Dolutegravir/Lamivudine (ABC/DTG/3TC) taken as a single tablet once daily for 20 weeks. They will then be randomly assigned to either continue ABC/DTG/3TC or switch to oral (tablet) Cabotegravir + Rilpivirine (CAB+RPV) . The participants will know which treatment they are receiving. Oral CAB+RPV will continue for 4 weeks, after which participants will switch to injectable CAB+RPV.
Participants randomised to CAB+RPV will then visit the study centre every 4 weeks. Participants randomised to ABC/DTG/3TC will have study visits every 4 weeks until week 48, then every 8 weeks until week 100. At week 100 they will be given the option to either complete the study, or switch to injectable CAB+RPV. Participants switching to injectable CAB+RPV will have study visits every 4 weeks
All participants taking injectable CAB+RPV will continue study visits until it is locally approved and available on prescription (expected June 2020), they no longer derive benefit from the treatment, they meet a protocol-defined reason for discontinuation or until development of the compound is terminated.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1494
Date of REC Opinion
16 Sep 2016
REC opinion
Further Information Favourable Opinion