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Immune Reconstitution in HIV Disease (IREHIV)

NCT01702974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2016-02-05

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

DRUG

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

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.

DRUG

Placebo tablets

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

Sponsors & Collaborators

  • Addis Ababa University

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Susanna Brighenti, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702974 on ClinicalTrials.gov