Folinic Acid: Supplementation and Therapy

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients infected by HIV or HIV-HCV coinfected have higher survival due to the use of HAART, but survival is accompanied by increased morbidity and associated cardiovascular disease (CVD). Endothelial dysfunction is an early marker of atherogenesis, acting as an intermediate in the causal pathway of CVD. Folinic acid (FA) has been shown to reduce CVD outcomes, especially among individuals with hyperhomocisteinemia.

To date, few studies provided consistent information about efficacy of pharmacological interventions that minimize damage to the vascular endothelium in patients infected by HIV or HIV-HCV coinfected. The main hypothesis of this study is that FA supplementation protects the vascular endothelium, and consequently might prevent subclinical atherosclerosis. Thus, the first step is to determine the efficacy of supplementation with FA, and to compare the effect between HIV and HIV-HCV coinfected.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Universidade Federal de Santa Maria
• Treatments: Folic Acid; Leucovorin; Levoleucovorin

Criteria

Inclusion criteria:

• HIV infected patients

• HIV-HCV coinfected patients

• 18-50 years

• men and women

• receiving HAART

• with undetectable viral load for more than six months.

Exclusion Criteria:

• Patients with diabetes mellitus,

• previous CVD: acute myocardial infarction, myocardial revascularization, or stroke,

• creatinine >1.5 mg/dL,

• clinical diagnosis or ultrasound, endoscopic, or laboratory evidence of liver cirrhosis,

• on treatment with: statins, fibrates, hormone replacement therapy, sulfonamides, vitamin supplements, or FA in the last 30 days,

• pregnant women.