Immune Reconstitution in HIV Disease (IREHIV)

Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01702974

Acronym

IREHIV

Enrollment

279

Registered

2012-10-10

Start date

2012-09-30

Completion date

2015-08-31

Last updated

2016-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV, cholecalciferol, sodium phenylbutyrate, antimicrobial peptides, immune response, inflammation

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

DRUGvitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

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.

DRUGPlacebo tablets

Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Adult patients \>18 years not subjected to HAART. HIV-1 infected patients with CD4 T cells counts \>200 cells/ml. Detectable plasma viral loads \>1000 copies/ml.

Exclusion criteria

Patients on HAART or other antimicrobial drugs (including bactrim). Antimicrobial drug treatment in the past month. Patients with medical contra-indication for biopsy such as bleeding tendencies. Hypercalcaemia (serum calcium \> 3,0 mmol/L) identified at baseline. Pregnant and breast feeding women. Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Design outcomes

Primary

Measure	Time frame	Description
HIV viral load	0 (baseline) compared to 16 weeks.	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).

Secondary

Measure	Time frame	Description
Clinical secondary endpoints	0, 4, 8, 16, 24 weeks.	Overall clinical symptoms. Body mass index (BMI). Mid upper arm circumference (MUAC).
Laboratory secondary endpoints	0, 4, 8, 16, 24 weeks.	HIV viral load (0, 4, 8, 24 weeks). Peripheral CD4/CD8 T cell counts. Plasma levels of vitamin D, LL-37, sCD14, LPS, 16S RNA and cytokine/chemokine profiles. Calprotectin in feces. Inflammation and microbial translocation in colon punch biopsies (0 and 16 weeks). Functional studies of immune cells (PBMCs).

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026