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

December 29, 2017 updated by: Göteborg University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Department of Infectious Diseases, Sahlgrenska university hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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: Pyridoxine
Drug: Folate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Declining NFL or decreased rate of increase of NFL
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Magnus Gisslén, MD, PhD, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-004311-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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