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

HIV Clinical Trial

Official title:

Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02773147
• Other study ID #: 2015-004311-20
• Status: Recruiting
• Phase: Phase 2
• First received: May 12, 2016
• Last updated: December 29, 2017
• Start date: April 2016
• Est. completion date: November 2018

Study information

• Verified date: December 2017
• Source: Göteborg University
• Contact: Magnus Gisslén, MD, PhD
• Phone: +46313436238
• Email: magnus.gisslen[@]infect.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Cyanocobalamin

• Folate

• Pyridoxine

Locations

Country	Name	City	State
Sweden	Department of Infectious Diseases, Sahlgrenska university hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Declining NFL or decreased rate of increase of NFL		One year