Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immune Reconstitution in HIV Disease (IREHIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Karolinska Institutet
Sponsor:
Collaborators:
Addis Ababa University
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
Information provided by (Responsible Party):
Susanna Brighenti, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01702974
First received: September 25, 2012
Last updated: October 8, 2012
Last verified: October 2012

September 25, 2012
October 8, 2012
September 2012
December 2015   (final data collection date for primary outcome measure)
HIV viral load [ Time Frame: 0 (baseline) compared to 16 weeks. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]

    Overall clinical symptoms.

    Body mass index (BMI).

    Mid upper arm circumference (MUAC).

  • Laboratory secondary endpoints [ Time Frame: 0, 4, 8, 16, 24 weeks. ] [ Designated as safety issue: Yes ]

    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
Interim analysis [ Designated as safety issue: Yes ]
An interim analysis will be performed after approx. 75-100 patients have been included into the study.
Same as current
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
200
December 2016
December 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 >5000 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 > 2.6 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Both
18 Years to 75 Years
No
Contact: Wondwossen Amogne, MD 251-911406179 wonamogne@yahoo.com
Contact: Endale Kassa, MD 251-911228562 endalekassalulu@gmail.com
Ethiopia
 
NCT01702974
IREHIV-2012
Yes
Susanna Brighenti, Karolinska Institutet
Karolinska Institutet
  • Addis Ababa University
  • Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
Principal Investigator: Susanna Brighenti, PhD Karolinska Institutet
Karolinska Institutet
October 2012

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