NCT03360682

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV-1-infection
• Solid Organ Transplant

Interventions

Type	Name	Description
DRUG	Lamivudine 300 MG	Lamivudine 300 MG/day (48 weeks)
DRUG	Abacavir 600 MG	Abacavir 600 MG/day (48 weeks)
DRUG	Dolutegravir 50 mg	Dolutegravir 50 MG/day (48 weeks)
DRUG	Tenofovir Disoproxil 245Mg Tablet	Tenofovir 245 MG/day (48 weeks)
DRUG	Emtricitabine 200 MG	Emtricitabine 200 MG/day (48 weeks)

Timeline

• Start date: 2018-04-13
• Primary completion: 2020-05-21
• Completion: 2020-05-21
• First posted: 2017-12-04
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

1 site across 1 country: Spain