Effect of rifabutin on oral cabotegravir in healthy subjects
Research type
Research Study
Full title
Phase I, single-center, open label, fixed-sequence cross-over study to evaluate the effect of rifabutin on the pharmacokinetics of oral cabotegravir in healthy subjects
IRAS ID
218792
Contact name
Kirsten Smith
Contact email
Sponsor organisation
GSK
Eudract number
2017-000103-25
Duration of Study in the UK
0 years, 2 months, 14 days
Research summary
It is estimated that 10% of HIV-infected individuals develop tuberculosis (TB) infection every year. Therefore, co-administration of anti-HIV and anti-TB drugs is required. ViiV Healthcare (ViiV) is developing a medicine to treat HIV-1 infection called Cabotegravir (CAB), which blocks an HIV virus protein preventing it from multiplying in the body.
Rifabutin (RBT) can be used for the treatment of tuberculosis. It can activate liver chemicals that break down drugs similar to CAB. Therefore, this study aims to assess whether there is an interaction between CAB and RBT, when dosed at the same time.
To do this, we will compare the amount of CAB that enters the bloodstream alone and in combination with RBT (both given orally). The safety of CAB alone and in combination with RBT will also be assessed.
This study will be conducted in 15 healthy, HIV negative volunteers. It consists of a screening visit, followed by two treatment periods and a follow-up visit. In Period 1, eligible participants will take a single oral tablet of CAB 30 milligram (mg) once a day for 14 days. In Period 2 starting on Day 15 after the last tablet of CAB, participants will take two oral capsules of RBT 150 mg (for a total dose of 300 mg) once a day along with a single oral tablet of CAB 30 mg once a day for 14 days. There will be a follow-up visit 10 - 14 days after the last oral tablet of CAB. The overall study duration will be approximately 10 weeks.
Taking part in the study will not have a direct benefit to volunteers. The study is sponsored by ViiV, and will be conducted in a MHRA accredited clinical research unit in the UK, with adequate safety and compliance facilities.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0193
Date of REC Opinion
21 Apr 2017
REC opinion
Favourable Opinion