SSAT064: PK of ABC/3TC/DTG in HIV patients of 60 years and over
Research type
Research Study
Full title
An open label study to investigate the safety and efficacy of abacavir/lamivudine/dolutegravir and the pharmacokinetic profile of dolutegravir in HIV-infected patients of 60 years of age and older
IRAS ID
170476
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2014-004970-40
Clinicaltrials.gov Identifier
REC Reference, 15/LO/0423
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The purpose of this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir.
These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection. Dolutegravir is a newly licenced anti-HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other well-known agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and we know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.
We aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.
The study will also assess the quality of life (well-being of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.If you decide to take part, the duration of your involvement in the study will be 6 months with an additional screening visit and a check-up visit 10 days after your end of study visit.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0423
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion