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Immune Reconstitution in HIV Disease (IREHIV) (IREHIV)

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 2

Locations

Ethiopia

Study Type

Interventional

Intervention

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, cholecalciferol, sodium phenylbutyrate, antimicrobial peptides, immune response, inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Clinical secondary endpoints

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

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).

Full Information

NCT ID

NCT01702974

First Posted

September 25, 2012

Last Updated

February 4, 2016

Sponsor

Karolinska Institutet

Collaborators

Addis Ababa University, Armauer Hansen Research Institute, Ethiopia

1. Study Identification

Unique Protocol Identification Number

NCT01702974

Brief Title

Immune Reconstitution in HIV Disease (IREHIV)

Acronym

IREHIV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Addis Ababa University, Armauer Hansen Research Institute, Ethiopia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo tablets

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Placebo tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

HIV viral load

Description

Time Frame

0 (baseline) compared to 16 weeks.

Secondary Outcome Measure Information:

Title

Clinical secondary endpoints

Description

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

Time Frame

0, 4, 8, 16, 24 weeks.

Title

Laboratory secondary endpoints

Description

Time Frame

0, 4, 8, 16, 24 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna Brighenti, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Addis Ababa

State/Province

Lideta sub city

Country

Ethiopia

12. IPD Sharing Statement

Citations:

PubMed Identifier

31330899

Citation

Missailidis C, Sorensen N, Ashenafi S, Amogne W, Kassa E, Bekele A, Getachew M, Gebreselassie N, Aseffa A, Aderaye G, Andersson J, Brighenti S, Bergman P. Vitamin D and Phenylbutyrate Supplementation Does Not Modulate Gut Derived Immune Activation in HIV-1. Nutrients. 2019 Jul 21;11(7):1675. doi: 10.3390/nu11071675.

Results Reference

derived

PubMed Identifier

30634590

Citation

Ashenafi S, Amogne W, Kassa E, Gebreselassie N, Bekele A, Aseffa G, Getachew M, Aseffa A, Worku A, Hammar U, Bergman P, Aderaye G, Andersson J, Brighenti S. Daily Nutritional Supplementation with Vitamin D(3) and Phenylbutyrate to Treatment-Naive HIV Patients Tested in a Randomized Placebo-Controlled Trial. Nutrients. 2019 Jan 10;11(1):133. doi: 10.3390/nu11010133.

Results Reference

derived

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Immune Reconstitution in HIV Disease (IREHIV)

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