Immune Reconstitution in HIV Disease (IREHIV)
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) (Drug); Placebo tablets (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Susanna Brighenti, PhD, Principal Investigator, Affiliation: Karolinska Institutet
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.
Clinical Details
Official title: Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: HIV viral load
Secondary outcome: Clinical secondary endpointsLaboratory secondary endpoints
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 > 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.
Locations and Contacts
Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine, Addis Ababa, Lideta sub city, Ethiopia
Additional Information
Starting date: September 2012
Last updated: July 8, 2015
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