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

NCT02773147 | Unknown Phase 2

• 1 other identifier: 2015-004311-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Declining NFL or decreased rate of increase of NFL

  One year

Study Arms (2)

Triobe

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Cyanocobalamin DRUG

Triobe

Folate DRUG

Triobe

Pyridoxine DRUG

Triobe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The ability to understand and give informed consent to participate.
• HIV-1 infected with stable ART \> 12 months
• Plasma HIV-RNA \< 50 copies/ml
• Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
• Male or female, age 18 or older.

You may not qualify if:

• Treatment with trimethoprim-sulfamethoxazole or methotrexate
• Ongoing B6, B12 or folate substitution
• Antiepileptic treatment
• Small bowel or ventricular resection
• Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
• Ongoing neurological disease or severe psychiatric disease
• Any malignant tumor in the history.
• Severe ongoing infection or opportunistic infection
• AUDIT \> 7 for men and \> 5 for women
• MADRS \> 20
• 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)).

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of Infectious Diseases, Sahlgrenska university hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Interventions

Vitamin B 12; Folic Acid; Pyridoxine

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Vitamin B 6; Picolines; Pyridines

Study Officials

• Magnus Gisslén, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Gisslén, MD, PhD

CONTACT

+46313436238; magnus.gisslen@infect.gu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 16, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 2, 2018

Record last verified: 2017-12

Locations

SE (1)