Overview
Immune Reconstitution in HIV Disease (IREHIV)
Status:
Completed
Completed
Trial end date:
2015-08-01
2015-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Karolinska InstitutetCollaborators:
Addis Ababa University
Armauer Hansen Research Institute, EthiopiaTreatments:
4-phenylbutyric acid
Anti-Infective Agents
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
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.