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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
| Armauer Hansen Research Institute, Ethiopia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) | Active Comparator | 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 Comparator | Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral load | Plasma HIV viral load will be used to monitor efficacy of vitamin D and phenylbutyrate treatment among treatment-naïve HIV patients at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at 16 weeks compared to baseline (time point 0). | 0 (baseline) compared to 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical secondary endpoints | Overall clinical symptoms. Body mass index (BMI). Mid upper arm circumference (MUAC). | 0, 4, 8, 16, 24 weeks. |
| Laboratory secondary endpoints | HIV viral load (0, 4, 8, 24 weeks). Peripheral CD4/CD8 T cell counts. Plasma levels of vitamin D, LL-37, sCD14, LPS, 16S RNA and cytokine/chemokine profiles. Calprotectin in feces. Inflammation and microbial translocation in colon punch biopsies (0 and 16 weeks). Functional studies of immune cells (PBMCs). |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Brighenti, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine | Addis Ababa | Lideta sub city | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31330899 | Derived | 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. | |
| 30634590 | Derived |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| C075773 | 4-phenylbutyric acid |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo tablets | Drug | Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks. |
|
| 0, 4, 8, 16, 24 weeks. |
| 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |