HIV-1Phase 4NCT02547844
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
A Phase 4 study testing efavirenz + emtricitabina + tenofovir and rilpivirina + emtricitabina + tenofovir in people with HIV-1, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- efavirenz + emtricitabina + tenofovir and rilpivirina + emtricitabina + tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Oct 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or above
- Patients infected with HIV-1
- Patients treated with Atripla at least the last 6 months.
- Patients with virologic suppression (HIV RNA <50 copies / ml) for at least the last 6 months.
- Women of childbearing potential must use contraception double barrier.
- Voluntary signature of informed consent
Who cannot join
- Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic
- Women pregnant or lactating
- Abuse of alcohol or other drugs
- Body Mass Index (BMI)> 25
- Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...)
- Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
- History or presence of allergy to any of the study drugs or their components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla®
To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.
- Conditions
- HIV-1
- Being tested
- efavirenz + emtricitabina + tenofovir, rilpivirina + emtricitabina + tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenz + emtricitabina + tenofovirDrug
Also called atripla
rilpivirina + emtricitabina + tenofovirDrug
Also called eviplera
| Study group | Role | What they receive |
|---|---|---|
| efavirenz + emtricitabina + tenofovir | Active comparator | Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir) Receives: Drug: efavirenz + emtricitabina + tenofovir |
| rilpivirina + emtricitabina + tenofovir | Experimental | Patients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir) Receives: Drug: rilpivirina + emtricitabina + tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547844
- Sponsor's protocol ID
- EfaRiLipidomics
- Status last verified
- Jun 2017
- First submitted
- 10 Sep 2015
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla®
- ClinicalTrials.gov ID
- NCT02547844
- Acronym / sponsor ID
- EfaRiLipidomics
- Conditions
- HIV-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Sep 2015 (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.
To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| efavirenz + emtricitabina + tenofovir | Active comparator | Drug: efavirenz + emtricitabina + tenofovirPatients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir) |
| rilpivirina + emtricitabina + tenofovir | Experimental | Drug: rilpivirina + emtricitabina + tenofovirPatients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years or above
- Patients infected with HIV-1
- Patients treated with Atripla at least the last 6 months.
- Patients with virologic suppression (HIV RNA <50 copies / ml) for at least the last 6 months.
- Women of childbearing potential must use contraception double barrier.
Key exclusion criteria (7 listed)
- Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic
- Women pregnant or lactating
- Abuse of alcohol or other drugs
- Body Mass Index (BMI)> 25
- Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...)
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 |
|---|---|---|
| efavirenz + emtricitabina + tenofovirAlso: atripla | Drug | efavirenz + emtricitabina + tenofovir |
| rilpivirina + emtricitabina + tenofovirAlso: eviplera | Drug | rilpivirina + emtricitabina + tenofovir |
Primary outcome
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
Time frame: 12 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 14 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing efavirenz + emtricitabina + tenofovir and rilpivirina + emtricitabina + tenofovir in people with HIV-1, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 7 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression. (time frame: 12 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 14 Jun 2017.