Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine

Sponsor
Göteborg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02773147
Collaborator
(none)
60
1
2
31
1.9

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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

  1. Declining NFL or decreased rate of increase of NFL [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 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.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT02773147
Other Study ID Numbers:
  • 2015-004311-20
First Posted:
May 16, 2016
Last Update Posted:
Jan 2, 2018
Last Verified:
Dec 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 2, 2018