HIV InfectionPhase 3FASTNCT02810275
Folinic Acid: Supplementation and Therapy
A Phase 3 study testing Folinic Acid in people with HIV Infection and HCV Coinfection, run by Hospital de Clinicas de Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infection, HCV Coinfection
- What is being tested?
- Folinic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected patients
- HIV-HCV coinfected patients
- 18-50 years
- men and women
- receiving HAART
- with undetectable viral load for more than six months.
Who cannot join
- 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.
About this study
Official title: Effect of Folic Acid on Homocysteine Levels and Flow-mediated Dilation in HIV and HIV-HCV Coinfected Patients: a Randomized Controlled Trial
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.
Read the detailed description
Study design: This was a randomized placebo-controlled trial, with blinding of health care team, participants, and investigators, in which the participants were randomly assigned in a 1:1 ratio to receive FA or placebo for four weeks.
Participants: Patients receiving care for HIV, at the outpatient clinic of the Hospital Universitario de Santa Maria, in southern Brazil, from October 2012 to September 2013, were recruited. Eligible participants: HIV infected or HIV-HCV coinfected patients, 18-50 years, men and women, receiving HAART, had undetectable viral load for more than six months. Patients were excluded: patients with diabetes mellitus, previous 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, and pregnant women.
Intervention Patients assigned to the intervention group received FA 5 mg, per oral, once a day, in the morning, during four weeks. Patients assigned to the placebo group received the same prescription. The trial provided FA and placebo in tablet form, identical in color, smell, taste, shape, and size. Both FA and placebo were prepared in a single batch, in an independent laboratory, by a pharmacist with no involvement in the trial. They were pre-packed in bottles containing 30 tablets each, individually labeled with an alphanumeric code and stored.
Outcomes The primary endpoint were changes in homocysteine, vitamin B12 levels, and brachial artery FMD during reactive hyperemia, as measured by Doppler ultrasound, from randomization to the end of follow-up. FMD was characterized by the variation in mean arterial flow measured as the peak change in vessel diameters relative to the baseline.
Sample size Sample size was calculated based on the results of a previous RCT,(14) which used plethysmography to measure FMD. To detect a difference of at least 6% between intervention and placebo groups, with standard deviations ranging from 5% to 7%, we calculated that a sample size of at least 17 patients per group, with randomization stratified by HCV coinfection status, was required to achieve 80% power and a 95% confidence interval.
- Conditions
- HIV Infection, HCV Coinfection
- Being tested
- Folinic Acid, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folinic AcidDrug
Also called FA
Folinic acid 5 mg, taking in the morning, daily, during four weeks
PlaceboDrug
Also called Control
Placebo capsule received 1 tablet, taking in the morning, during four weeks
| Study group | Role | What they receive |
|---|---|---|
| Folinic Acid | Experimental | Folinic acid group received 5 mg daily during four weeks Receives: Drug: Folinic Acid |
| Placebo | Placebo comparator | Placebo group received a tablet daily during four weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilatation
The response was defined by the variation in the flow mediated dilatation between intervention and placebo groups.
Measured: Four weeks
Secondary outcomes (1)
Serum homocysteine
Variation in the serum homocysteine between intervention and placebo groups.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Santa Maria
- Responsible party
- Principal investigator, Sandra Costa Fuchs, Hospital de Clinicas de Porto Alegre
- Investigators
- Sandra C Fuchs, PhD, MD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810275
- Sponsor's protocol ID
- CAAE: 00533612.8.0000.5346
- Other IDs
- GPPG-140240, RBR-9366qc
- Acronym
- FAST
- Status last verified
- Sep 2016
- First submitted
- 19 Jun 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Folic Acid on Homocysteine Levels and Flow-mediated Dilation in HIV and HIV-HCV Coinfected Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02810275
- Acronym / sponsor ID
- FAST / CAAE: 00533612.8.0000.5346
- Conditions
- HIV Infection, HCV Coinfection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Universidade Federal de Santa Maria
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: This was a randomized placebo-controlled trial, with blinding of health care team, participants, and investigators, in which the participants were randomly assigned in a 1:1 ratio to receive FA or placebo for four weeks.
Participants: Patients receiving care for HIV, at the outpatient clinic of the Hospital Universitario de Santa Maria, in southern Brazil, from October 2012 to September 2013, were recruited. Eligible participants: HIV infected or HIV-HCV coinfected patients, 18-50 years, men and women, receiving HAART, had undetectable viral load for more than six months. Patients were excluded: patients with diabetes mellitus, previous 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, and pregnant women.
Intervention Patients assigned to the intervention group received FA 5 mg, per oral, once a day, in the morning, during four weeks. Patients assigned to the placebo group received the same prescription. The trial provided FA and placebo in tablet form, identical in color, smell, taste, shape, and size. Both FA and placebo were prepared in a single batch, in an independent laboratory, by a pharmacist with no involvement in the trial. They were pre-packed in bottles containing 30 tablets each, individually labeled with an alphanumeric code and stored.
Outcomes The primary endpoint were changes in homocysteine, vitamin B12 levels, and brachial artery FMD during reactive hyperemia, as measured by Doppler ultrasound, from randomization to the end of follow-up. FMD was characterized by the variation in mean arterial flow measured as the peak change in vessel diameters relative to the baseline.
Sample size Sample size was calculated based on the results of a previous RCT,(14) which used plethysmography to measure FMD. To detect a difference of at least 6% between intervention and placebo groups, with standard deviations ranging from 5% to 7%, we calculated that a sample size of at least 17 patients per group, with randomization stratified by HCV coinfection status, was required to achieve 80% power and a 95% confidence interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folinic Acid | Experimental | Drug: Folinic AcidFolinic acid group received 5 mg daily during four weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group received a tablet daily during four weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- HIV infected patients
- HIV-HCV coinfected patients
- 18-50 years
- men and women
- receiving HAART
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folinic AcidAlso: FAFolinic acid 5 mg, taking in the morning, daily, during four weeks | Drug | Folinic Acid |
| PlaceboAlso: ControlPlacebo capsule received 1 tablet, taking in the morning, during four weeks | Drug | Placebo |
Primary outcome
Flow mediated dilatation
Time frame: Four weeks
The response was defined by the variation in the flow mediated dilatation between intervention and placebo groups.
1 secondary outcome
Serum homocysteine
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra C Fuchs, PhD, MD study chair
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folinic Acid in people with HIV Infection and HCV Coinfection, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilatation (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.