Immune Reconstitution in HIV Disease (IREHIV)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborators: Addis Ababa University; Armauer Hansen Research Institute, Ethiopia
• Treatments: 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.