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

Phase 2

• Conditions: HIV
• Interventions: Drug: Cyanocobalamin; Drug: Folate; Drug: Pyridoxine

• Registration Number: NCT02773147
• Lead Sponsor: Göteborg University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-02
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triobe	Folate	Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.
Triobe	Cyanocobalamin	Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.
Triobe	Pyridoxine	Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.

Primary Outcome Measures

Name	Time	Method
Declining NFL or decreased rate of increase of NFL	One year

Trial Locations

Locations (1)

Department of Infectious Diseases, Sahlgrenska university hospital; 🇸🇪 Gothenburg, Sweden