Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Triobe Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months. |
Drug: Cyanocobalamin
Drug: Folate
Drug: Pyridoxine
|
No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Declining NFL or decreased rate of increase of NFL [One year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The ability to understand and give informed consent to participate.
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HIV-1 infected with stable ART > 12 months
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Plasma HIV-RNA < 50 copies/ml
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Plasma homocysteine ≥ 12 μmol/L (subjects with < 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
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Male or female, age 18 or older.
Exclusion Criteria:
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Treatment with trimethoprim-sulfamethoxazole or methotrexate
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Ongoing B6, B12 or folate substitution
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Antiepileptic treatment
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Small bowel or ventricular resection
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Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
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Ongoing neurological disease or severe psychiatric disease
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Any malignant tumor in the history.
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Severe ongoing infection or opportunistic infection
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AUDIT > 7 for men and > 5 for women
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MADRS > 20
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Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)).
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Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Infectious Diseases, Sahlgrenska university hospital | Gothenburg | Sweden |
Sponsors and Collaborators
- Göteborg University
Investigators
- Principal Investigator: Magnus Gisslén, MD, PhD, Göteborg University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-004311-20