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Immune Reconstitution in HIV Disease (IREHIV) (IREHIV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702974
First Posted: October 10, 2012
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Addis Ababa University
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Susanna Brighenti, Karolinska Institutet
  Purpose
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.

Condition Intervention Phase
HIV Infection Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) Drug: Placebo tablets Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate

Resource links provided by NLM:


Further study details as provided by Susanna Brighenti, Karolinska Institutet:

Primary Outcome Measures:
  • HIV viral load [ Time Frame: 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:
  • Clinical secondary endpoints [ Time Frame: 0, 4, 8, 16, 24 weeks. ]

    Overall clinical symptoms.

    Body mass index (BMI).

    Mid upper arm circumference (MUAC).


  • Laboratory secondary endpoints [ Time Frame: 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).



Enrollment: 279
Study Start Date: September 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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 Comparator: Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Drug: Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702974


Locations
Ethiopia
Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine
Addis Ababa, Lideta sub city, Ethiopia
Sponsors and Collaborators
Karolinska Institutet
Addis Ababa University
Armauer Hansen Research Institute, Ethiopia
Investigators
Principal Investigator: Susanna Brighenti, PhD Karolinska Institutet
  More Information

Responsible Party: Susanna Brighenti, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01702974     History of Changes
Other Study ID Numbers: IREHIV-2012
First Submitted: September 25, 2012
First Posted: October 10, 2012
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Susanna Brighenti, Karolinska Institutet:
HIV
cholecalciferol
sodium phenylbutyrate
antimicrobial peptides
immune response
inflammation

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
4-phenylbutyric acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents