The main purpose of this study is to compare two different types of HIV treatments, in terms
of effectiveness and improvement of side effects, for patients who are diagnosed with a more
advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late
presenters'.
There are many effective treatments for HIV available; however, for late presenting patients
the investigators do not know which type of treatment performs best. This is the first large
study to compare treatments for patients in this situation, and the investigators hope that
the results of this study will help doctors decide which treatments to use in the future.
The two different types of treatment the investigators are comparing both contain a mixture
of drugs that work together to combat HIV:
The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing:
darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in
Europe under the brand name Symtuza®.
The Integrase Inhibitor combination (INI). Which is a combination tablet containing:
bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was
approved for use in Europe in June 2018 under the brand name of Biktarvy®.
The main difference between the two treatments is how each one fights a HIV infection. They
both stop a part of the virus from working (i.e. inhibit it), to prevent it from making
copies of itself. The PI treatment contains drugs to stop the protease part of the virus,
whereas the INI treatment contains drugs to stop the integrase part.
In recent studies, it appears that treatments containing integrase inhibitors may be better
for late presenting patients. They have been shown to quickly bring down the amount of virus
in the body, and the side effects may be more acceptable to late presenters.
To compare the two treatments, half of the participants on this study will be given the PI
treatment, and the other half will be given the INI treatment.
Phase:
Phase 3
Details
Lead Sponsor:
NEAT ID Foundation
Collaborators:
Gilead Sciences Janssen Pharmaceuticals
Treatments:
HIV Protease Inhibitors Integrase Inhibitors Protease Inhibitors