drugset / Trial / NCT00262522
Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.
Timeline
- Start
- 2005-11
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lopinavir | Other / unclassified | 400 mg | — |
| Comparator | Lopinavir | Other / unclassified | 800 mg | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | — |
| Comparator | Ritonavir | Other / unclassified | 200 mg | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Comparator | emtricitabine | Other / unclassified | 200 mg | — |