Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)
Status:
Completed
Trial end date:
2017-12-04
Target enrollment:
Participant gender:
Summary
The purpose of the study is to investigate the benefits of switching away from a kind of drug
called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients'
cardiovascular health (the health of their hearts). Patients are currently taking two other
anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their
boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the
boosted PI and dolutegravir more accurately, half of study participants will be switched to
dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on
the boosted PI.
Boosted PIs are associated with increased heart and circulation risk so it is hoped that
switching from a boosted PI to dolutegravir will improve the health of the patients' hearts.
Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in
the US and Europe. Clinical trials using dolutegravir have found that it is effective at
suppressing the HIV virus, and it is at least as effective as the other drugs.
This study will also investigate the safety (in terms of other side effects and the routine
blood tests which the investigators ordinarily use to monitor patients' treatment) and
monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment
from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in
their blood, and CD4 count is a measure of a type of cell that is in their immune system. We
also aim to improve patients' cardiovascular health in general by providing them with
information on how to live a healthy lifestyle (eg improving their diet, stopping smoking
etc).