drugset / Trial / NCT01702974
Immune Reconstitution in HIV Disease (IREHIV)
Phase 2
Completed
279 enrolled
Karolinska Institutet
Addis Ababa University · collabArmauer Hansen Research Institute, Ethiopia · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.
Timeline
- Start
- 2012-09
- Primary completion
- 2015-08
- Completion
- 2015-08
Publications
- Missailidis C, Sorensen N, Ashenafi S, Amogne W, Kassa E, Bekele A, Getachew M, Gebreselassie N, Aseffa A, Aderaye G, Andersson J, Brighenti S, Bergman P. Vitamin D and Phenylbutyrate Supplementation Does Not Modulate Gut Derived Immune Activation in HIV-1. Nutrients. 2019 Jul 21;11(7):1675. doi: 10.3390/nu11071675.
- Ashenafi S, Amogne W, Kassa E, Gebreselassie N, Bekele A, Aseffa G, Getachew M, Aseffa A, Worku A, Hammar U, Bergman P, Aderaye G, Andersson J, Brighenti S. Daily Nutritional Supplementation with Vitamin D(3) and Phenylbutyrate to Treatment-Naive HIV Patients Tested in a Randomized Placebo-Controlled Trial. Nutrients. 2019 Jan 10;11(1):133. doi: 10.3390/nu11010133.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cholecalciferol | Other / unclassified | 5000 iu | — |
| Comparator | Sodium Phenylbutyrate | Small molecule | 500 mg | — |