Folinic Acid: Supplementation and Therapy

NCT02810275 | Completed Phase 3

• 3 other identifiers: CAAE: 00533612.8.0000.5346GPPG-140240RBR-9366qc
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infection; HCV Coinfection

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilatation

  The response was defined by the variation in the flow mediated dilatation between intervention and placebo groups.

  Four weeks

Secondary Outcomes (1)

• Serum homocysteine

  Four weeks

Other Outcomes (1)

• Blood pressure

  Four weeks

Study Arms (2)

Folinic Acid

EXPERIMENTAL

Folinic acid group received 5 mg daily during four weeks

Drug: Folinic Acid

Placebo

PLACEBO COMPARATOR

Placebo group received a tablet daily during four weeks

Drug: Placebo

Interventions

Folinic Acid DRUG

Folinic acid 5 mg, taking in the morning, daily, during four weeks

Also known as: FA

Folinic Acid

Placebo DRUG

Placebo capsule received 1 tablet, taking in the morning, during four weeks

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV infected patients
• HIV-HCV coinfected patients
• years
• men and women
• receiving HAART
• with undetectable viral load for more than six months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Universidade Federal de Santa Maria: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Sandra C Fuchs, PhD, MD

  Hospital de Clinicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 22, 2016
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share