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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
HIV therapy will be adapted: atazanavir 400mg QD
HIV therapy will be adapted: dolutegravir 50mg QD
HIV therapy will be adapted: lamivudine 300mg QD
University of Bonn
Bonn, Germany
Rijstate
Arnhem, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
St. Elisabeth
Tilburg, Netherlands
Area under the plasma concentration versus time curve (AUC) of atazanavir, dolutegravir and lamivudine
Pharmacokinetic parameters of atazanavir, dolutegravir and lamivudine
Time frame: week 2
efficacy (viral load)
efficacy (viral load) of the combination of atazanavir, dolutegravir and lamivudine
Time frame: week 2, 6 and 12
number of adverse events
number of adverse events of the combination of atazanavir, dolutegravir and lamivudine
Time frame: week 2, 6 and 12
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