Completed
PHASE2
INTERVENTIONAL
NCT01702974
Immune Reconstitution in HIV Disease (IREHIV)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Type:
DRUG
Description:
Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
Name:
Placebo tablets
Type:
DRUG
Description:
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Primary Outcomes
Measure:
HIV viral load
TimeFrame:
0 (baseline) compared to 16 weeks.
Description:
Plasma HIV viral load will be used to monitor efficacy of vitamin D and phenylbutyrate treatment among treatment-naïve HIV patients at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at 16 weeks compared to baseline (time point 0).
Trial Information
NCT ID
NCT01702974
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Karolinska Institutet
Last Updated
December 15, 2025