Immune Reconstitution in HIV Disease (IREHIV)

NCT01702974 | Completed Phase 2 DMC

• 1 other identifier: IREHIV-2012
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Clinical secondary endpoints

  0, 4, 8, 16, 24 weeks.

• Laboratory secondary endpoints

  0, 4, 8, 16, 24 weeks.

Study Arms (2)

Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

ACTIVE COMPARATOR

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.

Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets

PLACEBO COMPARATOR

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

Drug: Placebo tablets

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.

Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets DRUG

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

Placebo tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Addis Ababa University: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Study Sites (1)

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

Addis Ababa, Lideta Sub City, Ethiopia

Location

Related Publications (2)

• 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.

  PMID: 31330899 DERIVED

• 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.

  PMID: 30634590 DERIVED

MeSH Terms

Conditions

HIV Infections; Inflammation

Interventions

Vitamin D; Cholecalciferol; 4-phenylbutyric acid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Susanna Brighenti, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 10, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

ET (1)