The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Lamivudine 300 MG/day (48 weeks)
Abacavir 600 MG/day (48 weeks)
Dolutegravir 50 MG/day (48 weeks)
Tenofovir 245 MG/day (48 weeks)
Emtricitabine 200 MG/day (48 weeks)
Hospital Clínic de Barcelona
Barcelona, Spain
Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant
Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)
Time frame: 24-hours before the switch and 24-hours 2 weeks after switching
Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant
Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).
Time frame: 24-hours before the switch and 24-hours 2 weeks after switching
Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant
Time frame: 24-hours before the switch and 24-hours 2 weeks after switching
Viral Resistance
number op patients with VIH viral load \> 50 copies/mL virological failure.
Time frame: week 48
Changes in CD4+ Cell
To assess the changes in CD4+ cell count \>200 cel/mL in peripheral blood.
Time frame: week 48
Lipid Profile
To assess the changes in lipid profile (triglycerides)
Time frame: week 48
Renal Function
To assess creatinine \>normal valors mg/dl\> 120 mg/dl
Time frame: week 48
Safety: Number AEs and SAEs
number AEs and SAEs
Time frame: week 48
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