Immune Reconstitution in HIV Disease (IREHIV)

Karolinska Institute

Status and phase: Completed; Phase 2

Conditions: HIV Infection

Treatments: Drug: Placebo tablets; Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT01702974

IREHIV-2012

Details and patient eligibility

About

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.

Enrollment: 279 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

279 participants in 2 patient groups, including a placebo group

Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Active Comparator group

Description:

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.

Treatment:

Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets

Placebo Comparator group

Description:

Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

Treatment:

Drug: Placebo tablets