HIV
Conditions
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
Interventions
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The ability to understand and give informed consent to participate. 2. HIV-1 infected with stable ART \> 12 months 3. Plasma HIV-RNA \< 50 copies/ml 4. Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4). 5. Male or female, age 18 or older.
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. AUDIT \> 7 for men and \> 5 for women 10. MADRS \> 20 11. 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)). 12. Pregnancy at screening visit, or planning pregnancy during study period is an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Declining NFL or decreased rate of increase of NFL | One year |
Countries
Sweden
Contacts
Primary ContactMagnus Gisslén, MD, PhD
Outcome results
None listed