drugset / Trial / NCT01301066
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Phase 4
Completed
252 enrolled
Kowa Research Institute, Inc.
Eli Lilly and Company · collabKowa Pharmaceuticals America, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Timeline
- Start
- 2010-12
- Primary completion
- 2013-03
- Completion
- 2013-03
Outcome
Met primary endpoint
paper LDL cholesterol reduction was 31·1% with pitavastatin and 20·9% with pravastatin (least squares mean difference -9·8%, 95% CI -13·8 to -5·9; PMID 28416195 ↗
paper p<0·0001 PMID 28416195 ↗
Publications
- Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
- Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427.
- Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitavastatin | Small molecule | 4 mg | Oral |
| Comparator | Pravastatin | Small molecule | 40 mg | Oral |