HIV
Conditions
Interventions
Trade Name: Triobe
Product Name: Triobe
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyanocobalamin
Other descriptive name: CYANOCOBALAMIN
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Gothenburg University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The ability to understand and give informed consent to participate. 2. Stable ART > 12 months 3. Plasma HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Treatment with trimethoprim-sulfamethoxazole or methotrexate 2. Ongoing B6, B12 or folate substitution 3. Antiepileptic treatment 4. Small bowel or ventricular resection 5. Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease) 6. Ongoing neurological disease or severe psychiatric disease 7. Any malignant tumor in the history. 8. Severe ongoing infection or opportunistic infection 9. Pregnancy 10. AUDIT > 7 for men and > 5 for women 11. MADRS > 20 12. Significant B12 or folate deficiency that indicate substitution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if treatment with B vitamins effect the rate of neuronal damage measured by plasma NFL in HIV-infected individuals;Secondary Objective: Effect on neurocognitive performance Effect on homocysteine levels ;Primary end point(s): Changes in P-NFL levels in the Triobe-arm compared to controls from baseline to 12 months;Timepoint(s) of evaluation of this end point: 1, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 months and 24 months;Secondary end point(s): 1. Changes in neuropsychological assessment measured by Cogstate compared to controls after 12 months 2. Changes in P-NFL and Cogstate levels from baseline after 24 months of Triobe treatment 3. Assessing relationship between P-homocysteine levels and P-NFL at baseline (all screened subjects included in this analysis, also those with P homocysteine < 12). 4. Changes in P-NFL and Cogstate in the period between 12 and 24 months compared with the period between 0 and 12 months in the control group, i.e. during the period on compared to off Triobe treatment in the control group. | — |
Countries
Sweden
Contacts
Public ContactMagnus Gisslen
Göteborgs universitet
Outcome results
None listed