drugset / Trial / NCT00626301
Lopinavir/Ritonavir Monotherapy in Children
Phase 4
Completed
40 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University · collabKhon Kaen University · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).
Timeline
- Start
- 2007-11
- Primary completion
- 2009-09
- Completion
- 2009-09
Publications
- Results Bunupuradah T, Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit T, Lumbiganon P, Chuanjaroen T, Sopharak C, Udompanit T, Prasitsuebsai W, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Simplifying antiretroviral therapy to lopinavir/ritonavir monotherapy did not improve quality of life and therapy adherence in pretreated HIV-infected children. AIDS Res Hum Retroviruses. 2014 Mar;30(3):260-5. doi: 10.1089/AID.2013.0204. Epub 2013 Dec 21.
- Results Kosalaraksa P, Ananworanich J, Puthanakit T, Pinyakorn S, Lumbiganon P, Chuanjaroen T, Chobkarjing U, Phanuphak P, Pancharoen C, Bunupuradah T; HIV-NAT 077 Study Team. Long-term lopinavir/ritonavir monotherapy in HIV-infected children. Pediatr Infect Dis J. 2013 Apr;32(4):350-3. doi: 10.1097/INF.0b013e31827b1bd3.
- Results Bunupuradah T, Kosalaraksa P, Puthanakit T, Mengthaisong T, Wongsabut J, Lumbiganon P, Phanuphak P, Burger D, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in virologically suppressed children. AIDS. 2011 Jan 28;25(3):315-23. doi: 10.1097/QAD.0b013e32834231f5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lopinavir/ritonavir | Unknown | 57.5 mg/m2 | Oral |
| Subject | lopinavir/ritonavir | Unknown | 230 mg/m2 | Oral |