Immune Reconstitution in HIV Disease (IREHIV)

Karolinska Institutet279 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

279

Conditions

HIV Infection

Interventions

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)DRUG

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.

Placebo tabletsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine

Addis Ababa, Lideta sub city, Ethiopia

Outcomes

Primary Outcomes

HIV viral load

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).

Time frame: 0 (baseline) compared to 16 weeks.

Secondary Outcomes

Clinical secondary endpoints

Overall clinical symptoms. Body mass index (BMI). Mid upper arm circumference (MUAC).

Time frame: 0, 4, 8, 16, 24 weeks.

Laboratory secondary endpoints

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).

Time frame: 0, 4, 8, 16, 24 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.