Study Results
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Basic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2012-09-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Interventions
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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.
Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
HIV-1 infected patients with CD4 T cells counts \>200 cells/ml.
Detectable plasma viral loads \>1000 copies/ml.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Addis Ababa University
OTHER
Armauer Hansen Research Institute, Ethiopia
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Susanna Brighenti
Associate professor
Principal Investigators
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Susanna Brighenti, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine
Addis Ababa, Lideta Sub City, Ethiopia
Countries
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References
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Missailidis C, Sorensen N, Ashenafi S, Amogne W, Kassa E, Bekele A, Getachew M, Gebreselassie N, Aseffa A, Aderaye G, Andersson J, Brighenti S, Bergman P. Vitamin D and Phenylbutyrate Supplementation Does Not Modulate Gut Derived Immune Activation in HIV-1. Nutrients. 2019 Jul 21;11(7):1675. doi: 10.3390/nu11071675.
Ashenafi S, Amogne W, Kassa E, Gebreselassie N, Bekele A, Aseffa G, Getachew M, Aseffa A, Worku A, Hammar U, Bergman P, Aderaye G, Andersson J, Brighenti S. Daily Nutritional Supplementation with Vitamin D(3) and Phenylbutyrate to Treatment-Naive HIV Patients Tested in a Randomized Placebo-Controlled Trial. Nutrients. 2019 Jan 10;11(1):133. doi: 10.3390/nu11010133.
Other Identifiers
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IREHIV-2012
Identifier Type: -
Identifier Source: org_study_id
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