HIVPhase 3NCT01034917
Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
A Phase 3 study testing Etravirine 400 mg dissolved in water every 24 hours and Continue with the same antiretroviral regimen in people with HIV, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial. Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV
- What is being tested?
- Etravirine 400 mg dissolved in water every 24 hours and Continue with the same antiretroviral regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Dec 2011
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient having a diagnosis of HIV-1 infection.
- Antiretroviral therapy started at least 12 months before, always with a HAART combination including 2 NRTIs plus a PI.
- Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) since the beginning of antiretroviral therapy, for at least 6 months.
- Absence of suspected or documented resistance mutations in the RT associated to NNRTIs or to any NRTI.
- Patient having at least one of the following conditions:
- Dyslipemia (LDL cholesterol >130 mg/dL or triglycerides > 350 mg/dL) derived from their current PI regimen or current use of lipid-lowering agents due to dyslipemia,
Show all 10Show fewer
- Antiretroviral-related gastrointestinal disturbances, or
- Low patient's satisfaction associated with the current regimen posology (BID regimen, ritonavir use, ritonavir intolerance…).
- Good treatment adherence.
- Voluntary written informed consent.
Who cannot join
- Previous therapy with mono or dual antiretroviral therapies after initial of HAART era.
- Previous antiretroviral treatment failures, treatment interruptions (A) or blips (B) in viral load (VL > 50 copies/mL).
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
- Clinically significant malabsorption syndrome within 30 days prior to randomization.
- Patients who in the past made any interruption of treatment (provide that it has not been in the last year) may be considered candidates for the study, if they meet other criteria for inclusion, since the break in the treatment should not assume the emergence of mutations.
- Small blips that are preceded or forwarded by 2 undetectable viral loads will not be taken in care.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Germans Trias i Pujol University Hospital
Badalona, Barcelona, 08916
About this study
Official title: Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The aim of the study is to compare the virological efficacy of the etravirine-based regimen with standard PI-containing regimen.
Read the detailed description
Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the European Medicines Agency in September 2008 for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI and other antiretroviral classes.
A question that has not been explored is whether subjects with sustained undetectable HIV-1 RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to etravirine. This treatment strategy could allow improvements in tolerability and lipid profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We designed a proof-of-concept study to test the efficacy and safety of switching from a Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral strategy of simplification therapy, based on the high antiviral potency, low toxicity, together with its easy posology (in water dissolution).
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
- Conditions
- HIV
- Being tested
- Etravirine 400 mg dissolved in water every 24 hours, Continue with the same antiretroviral regimen
- Keywords
- Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other, Treatment Experienced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etravirine 400 mg dissolved in water every 24 hoursDrug
Also called ETV
Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
Continue with the same antiretroviral regimenDrug
Also called CNT
Continue with the same antiretroviral regimen
| Study group | Role | What they receive |
|---|---|---|
| Etravirine group | Experimental | To switch from the PI to Etravirine 400 mg dissolved in water every 24 hours Receives: Drug: Etravirine 400 mg dissolved in water every 24 hours |
| Control group | Active comparator | Continue with the same antiretroviral regimen Receives: Drug: Continue with the same antiretroviral regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Measured: week 48 after baseline
Secondary outcomes (8)
CD4+/CD8+ T lymphocytes count
Measured: evolution from baseline to week 48
Genotypic test
Measured: if virologic failure occurs
Lipid profile: total, HDL-, LDL-cholesterol and triglyceride levels
Measured: evolution from baseline to week 48
Administration of lipid-lowering drugs throughout the study
Measured: from baseline to week 48
Cardiovascular risk assessed by the SCORE equation
Measured: evolution from baseline to week 48
Patient's satisfaction assessed by 2 scales of type Likert
Measured: evolution from baseline to week 48
Adverse events related to antiretroviral treatment
Measured: from baseline to week 48
Etravirine plasma trough concentration
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra. EUGENIA NEGREDO PUIGMAL, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Investigators
- Eugenia Negredo, MD,PhD, Principal investigator, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034917
- Sponsor's protocol ID
- ETRA-SWITCH
- Status last verified
- Jan 2020
- First submitted
- 17 Dec 2009
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Echeverria P, Bonjoch A, Puig J, Molto J, Paredes R, Sirera G, Ornelas A, Perez-Alvarez N, Clotet B, Negredo E. Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study. PLoS One. 2014 Feb 4;9(2):e84676. doi: 10.1371/journal.pone.0084676. eCollection 2014.
PubMed 24503952
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression
- ClinicalTrials.gov ID
- NCT01034917
- Acronym / sponsor ID
- ETRA-SWITCH
- Conditions
- HIV
- Keywords
- Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Dec 2009 (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.
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The aim of the study is to compare the virological efficacy of the etravirine-based regimen with standard PI-containing regimen.
Detailed description
Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the European Medicines Agency in September 2008 for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI and other antiretroviral classes.
A question that has not been explored is whether subjects with sustained undetectable HIV-1 RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to etravirine. This treatment strategy could allow improvements in tolerability and lipid profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We designed a proof-of-concept study to test the efficacy and safety of switching from a Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral strategy of simplification therapy, based on the high antiviral potency, low toxicity, together with its easy posology (in water dissolution).
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etravirine group | Experimental | Drug: Etravirine 400 mg dissolved in water every 24 hoursTo switch from the PI to Etravirine 400 mg dissolved in water every 24 hours |
| Control group | Active comparator | Drug: Continue with the same antiretroviral regimenContinue with the same antiretroviral regimen |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patient having a diagnosis of HIV-1 infection.
- Antiretroviral therapy started at least 12 months before, always with a HAART combination including 2 NRTIs plus a PI.
- Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) since the beginning of antiretroviral therapy, for at least 6 months.
- Absence of suspected or documented resistance mutations in the RT associated to NNRTIs or to any NRTI.
- Patient having at least one of the following conditions:
Key exclusion criteria (7 listed)
- Previous therapy with mono or dual antiretroviral therapies after initial of HAART era.
- Previous antiretroviral treatment failures, treatment interruptions (A) or blips (B) in viral load (VL > 50 copies/mL).
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
- Clinically significant malabsorption syndrome within 30 days prior to randomization.
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 |
|---|---|---|
| Etravirine 400 mg dissolved in water every 24 hoursAlso: ETVSwitch from the PI to Etravirine 400 mg dissolved in water every 24 hours | Drug | Etravirine group |
| Continue with the same antiretroviral regimenAlso: CNTContinue with the same antiretroviral regimen | Drug | Control group |
Primary outcome
Viral load
Time frame: week 48 after baseline
8 secondary outcomes
CD4+/CD8+ T lymphocytes count
Time frame: evolution from baseline to week 48
Genotypic test
Time frame: if virologic failure occurs
Lipid profile: total, HDL-, LDL-cholesterol and triglyceride levels
Time frame: evolution from baseline to week 48
Administration of lipid-lowering drugs throughout the study
Time frame: from baseline to week 48
Cardiovascular risk assessed by the SCORE equation
Time frame: evolution from baseline to week 48
Patient's satisfaction assessed by 2 scales of type Likert
Time frame: evolution from baseline to week 48
Adverse events related to antiretroviral treatment
Time frame: from baseline to week 48
Etravirine plasma trough concentration
Time frame: Week 4
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 31 Jan 2020.
- Derived from this study: PubMed 24503952Echeverria P, Bonjoch A, Puig J, Molto J, Paredes R, Sirera G, Ornelas A, Perez-Alvarez N, Clotet B, Negredo E. Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study. PLoS One. 2014 Feb 4;9(2):e84676. doi: 10.1371/journal.pone.0084676. eCollection 2014.
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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.
Eugenia Negredo, MD,PhD principal investigator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etravirine 400 mg dissolved in water every 24 hours and Continue with the same antiretroviral regimen in people with HIV, run by Germans Trias i Pujol Hospital 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 10 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 31 Jan 2020. 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 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?
Viral load (time frame: week 48 after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034917, which also lists 1 linked publication.
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 31 Jan 2020.