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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 endpoints

Laboratory 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

Page last updated: August 23, 2015

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