drugset / Trial / NCT00802334
TDM of Generic Lopinavir/Ritonavir 200/50 mg
Phase 2
Completed
70 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
The Government Pharmaceutical Organization · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Evaluating the bioavailibility safety and efficacy of the generic LPV/RTV 200/50 mg tablet formulation in a 400/100 mg BID dose in Thai HIV infected individuals.
Timeline
- Start
- 2008-01
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Results Ramautarsing RA, van der Lugt J, Gorowara M, Sophonphan J, Ananworanich J, Lange JM, Burger DM, Phanuphak P, Ruxthungtham K, Avihingsanon A. Pharmacokinetics and 48-week safety and efficacy of generic lopinavir/ritonavir in Thai HIV-infected patients. Antivir Ther. 2013;18(2):249-52. doi: 10.3851/IMP2324. Epub 2012 Aug 23.
- van der Lugt J, Lange J, Avihingsanon A, Ananworanich J, Sealoo S, Burger D, Gorowara M, Phanuphak P, Ruxrungtham K. Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals. Antivir Ther. 2009;14(7):1001-4. doi: 10.3851/IMP1410.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir | Other / unclassified | 400 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |