drugset / Trial / NCT02509195

SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over

NCT02509195

Phase 4 Completed 40 enrolled St Stephens Aids Trust ViiV Healthcare · collab
NaSingle-groupOpen-labelTreatment

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 wellknown 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 the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals. The investigators 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 (wellbeing 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. The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.

Timeline

Start
2015-08-04
Primary completion
2017-02-13
Completion
2017-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Abacavir Other / unclassified 600 mg Oral
Subject Dolutegravir Other / unclassified 50 mg Oral
Subject Lamivudine Other / unclassified 300 mg Oral