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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
September 25, 2012
October 10, 2012
February 5, 2016
September 2012
August 2015   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01702974 on ClinicalTrials.gov Archive Site
  • 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).

Same as current
Not Provided
Interim analysis
An interim analysis will be performed after approx. 75-100 patients have been included into the study.
 
Immune Reconstitution in HIV Disease (IREHIV)
Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infection
  • 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.
  • Drug: Placebo tablets
    Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
  • 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.
    Intervention: Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
  • Placebo Comparator: Placebo tablets
    Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
    Intervention: Drug: Placebo tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
279
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
 
NCT01702974
IREHIV-2012
Yes
Not Provided
Not Provided
Susanna Brighenti, Karolinska Institutet
Karolinska Institutet
  • Addis Ababa University
  • Armauer Hansen Research Institute, Ethiopia
Principal Investigator: Susanna Brighenti, PhD Karolinska Institutet
Karolinska Institutet
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP