Immune Reconstitution in HIV Disease (IREHIV)

HIV Infection Clinical Trial

— IREHIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702974
• Other study ID #: IREHIV-2012
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: February 4, 2016
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine	Addis Ababa	Lideta sub city

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Addis Ababa University, Armauer Hansen Research Institute, Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 (baseline) compared to 16 weeks.	Yes
Secondary	Clinical secondary endpoints	Overall clinical symptoms.; Body mass index (BMI).; Mid upper arm circumference (MUAC).	0, 4, 8, 16, 24 weeks.	Yes
Secondary	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).	0, 4, 8, 16, 24 weeks.	Yes