Immune Reconstitution in HIV Disease (IREHIV)

Phase 2

Completed

• Conditions: HIV Infection
• Interventions: Drug: Placebo tablets; Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

• Registration Number: NCT01702974
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo tablets	Placebo tablets	Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)	vitamin 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine; 🇪🇹 Addis Ababa, Lideta sub city, Ethiopia