A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
Current HIV treatment guidelines recommend a combination of drugs for the maintenance of
antiretroviral therapy (ART). Simplification is considered critical to further scale-up of
treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily
integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance
profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in
maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on
conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors
(NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is
the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing
virological failure.