drugset / Trial / 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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-04-13
- Primary completion
- 2020-05-21
- Completion
- 2020-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 600 mg | — |
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Lamivudine | Other / unclassified | 300 mg | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 245 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |