Evaluation of folinic acid supplementation, to prevent dysfunction of blood vessels in patients with HIV and HIV-HCV

Not Applicable

• Conditions: Chronic Hepatitis C, Endothelial Dysfunction, Atherosclerosis; B20-B24; B18.2; C14.907.137.126.307; A11.436.275

• Registration Number: RBR-9366qc
• Lead Sponsor: Fabio Lopes Pedro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Monoinfected patients by with HIV; or HCV-HIV co-infected; using antiretroviral therapy; who signed an consent form.

Exclusion Criteria

history of diabetes mellitus; acute myocardial infarction; renal insufficiency (creatinine current> 1.5); stroke; clinical signs and / or laboratory evidence of liver cirrhosis (ascites, hepatic encephalopathy present or recent upper gastrointestinal bleeding, esophageal varices present, liver ultrasound with signs suggestive of cirrhosis, biopsy Metavir F4); current pregnancy; recent use (last 30 days) of: statins, fibrates, hormone replacement therapy, sulfonamides (sulfamethoxazole, sulfadiazine), vitamin supplements, or similar of folinic acid and / or folic acid; Individuals with restriction or inability to understand and decide for their participation in the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the vascular response of the brachial artery during reactive hyperemia, as measured by Doppler ultrasound before and after the intervention. The variation of at least 20% of the flow is considered positive outcome.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are changes in biochemical and hemodynamic variables at baseline and after interventions. Laboratory analysis (serum): homocysteine,folic acid, vitamin B12, creatinine, fasting glucose, cholesterol, (total, high and low density), triglycerides. Will be measured blood pressure, heart rate, weight, height.