Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
During the past years the treatment of HIV-1 infection has transformed towards chronic
treatment. Patients are being treated with antiretroviral drugs for many years and become
older. The risk of developing side-effects due to long term antiretroviral therapy is
therefore more and more likely. New alternative once-daily maintenance regimes are needed for
those who are extensively pre-treated and experience side-effects or toxicity on standard
treatment combinations. A possible once-daily, fully active maintenance regimen is the
combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen). This
combination is expected to be a safe, once-daily maintenance regimen with a favorable
side-effect profile. The combination suits patients with intolerance and/or resistance to
NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new
combination the pharmacokinetic profile is unknown and there are no data on short-term and
long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety
and efficacy in a small number of HIV-1 infected patients.