drugset / Trial / NCT01307124
Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)
Phase 3
Completed
199 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute · collabBuddhachinaraj Hospital · collabChulalongkorn University · collabNakornping Hospital · collabPhrachomklao Hospital · collabPrapokklao Hospital · collabQueen Sirikit National Institute of Child Health · collabSappasitthiprasong Hospital · collabSrinagarind Hospital, Khon Kaen University · collabSurin Hospital · collabUdonThani Hospital · collab
RandomizedFactorialOpen-labelTreatment
Summary
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load \< 50 copies/ml at 48 week
Timeline
- Start
- 2011-03
- Primary completion
- 2013-04
- Completion
- 2013-04
Publications
- Results A randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression . Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation.
- Results Association of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children. Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation and 5th International Workshop on HIV Pediatrics in June 28-29, 2013 in Kuala Lumpur, Malaysia
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir/ritonavir | Unknown | 200 mg | — |
| Subject | Lopinavir/ritonavir | Unknown | 300 mg | — |
| Subject | Lopinavir/ritonavir | Unknown | 400 mg | — |