drugset / Trial / NCT02116660
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.
Timeline
- Start
- 2014-09-03
- Primary completion
- 2017-07-10
- Completion
- 2017-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atazanavir | Other / unclassified | 300 mg | Oral |
| Comparator | Darunavir | Small molecule | 400 mg | Oral |
| Comparator | Darunavir | Small molecule | 600 mg | Oral |
| Comparator | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 150 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 200 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 400 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 800 mg | Oral |
| Subject | Nevirapine | Small molecule | 200 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 100 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 200 mg | Oral |
| Comparator | Tenofovir | Small molecule | 300 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |