Hospital Clínic de Barcelona
Barcelona, 08036, Spain
NCT Number: NCT03360682
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Barcelona, 08036, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lamivudine 300 MG/day (48 weeks)
Other names: J05AF05
Abacavir 600 MG/day (48 weeks)
Other names: J05AF06
Dolutegravir 50 MG/day (48 weeks)
Other names: J05AX12
Tenofovir 245 MG/day (48 weeks)
Other names: J05AF07
Emtricitabine 200 MG/day (48 weeks)
Other names: J05AF09
Time frame: 24-hours before the switch and 24-hours 2 weeks after switching
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 immunosuppressant Mycophenolic Acid (MPA).
Time frame: 24-hours before the switch and 24-hours 2 weeks after switching
Time frame: week 48
number op patients with VIH viral load > 50 copies/mL virological failure.
Time frame: week 48
To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.
Time frame: week 48
To assess the changes in lipid profile (triglycerides)
Time frame: week 48
To assess creatinine >normal valors mg/dl> 120 mg/dl
Time frame: week 48
number AEs and SAEs
Fundacion Clinic per a la Recerca Biomédica
Other
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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