Effect of vitamin B treatment on brain damage and cognition in HIV-infected individuals with high levels of homocysteine in blood.

• Conditions: HIV; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-004311-20-SE
• Lead Sponsor: Gothenburg University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-14
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The ability to understand and give informed consent to participate.
2. Stable ART > 12 months
3. Plasma HIV-RNA <50 copies/ml
4. Elevated plasma homocysteine

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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. Pregnancy
10. AUDIT > 7 for men and > 5 for women
11. MADRS > 20
12. Significant B12 or folate deficiency that indicate substitution

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified