|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 January 2018 |
|
Main ID: |
NCT02773147 |
|
Date of registration:
|
12/05/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine
|
|
Scientific title:
|
Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine |
|
Date of first enrolment:
|
April 2016 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02773147 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Contacts
|
|
Name:
|
Magnus Gisslén, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Göteborg University |
|
|
Name:
|
Magnus Gisslén, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+46313436238 |
|
Email:
|
magnus.gisslen@infect.gu.se |
|
Affiliation:
|
|
|
|
Name:
|
Magnus Gisslén, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+46313436238 |
|
Email:
|
magnus.gisslen@infect.gu.se |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
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
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.)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV
|
|
Intervention(s)
|
|
Drug: Pyridoxine
|
|
Drug: Cyanocobalamin
|
|
Drug: Folate
|
|
Primary Outcome(s)
|
|
Declining NFL or decreased rate of increase of NFL
[Time Frame: One year]
|
|
Secondary ID(s)
|
|
2015-004311-20
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|