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Immune Reconstitution in HIV Disease (IREHIV) (IREHIV)

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.
 
ClinicalTrials.gov Identifier: NCT01702974
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : February 5, 2016
Sponsor:
Collaborators:
Addis Ababa University
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Susanna Brighenti, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE September 25, 2012
First Posted Date  ICMJE October 10, 2012
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2012)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: October 8, 2012)
Interim analysis
An interim analysis will be performed after approx. 75-100 patients have been included into the study.
 
Descriptive Information
Brief Title  ICMJE Immune Reconstitution in HIV Disease (IREHIV)
Official Title  ICMJE Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2016)
279
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2012)
200
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01702974
Other Study ID Numbers  ICMJE IREHIV-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susanna Brighenti, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE
  • Addis Ababa University
  • Armauer Hansen Research Institute, Ethiopia
Investigators  ICMJE
Principal Investigator: Susanna Brighenti, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date February 2016

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