HIVPhase 4NCT00966329
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
A Phase 4 study testing maraviroc in people with HIV and HIV Infections, run by Germans Trias i Pujol Hospital at 3 sites in Spain.
Trial summary
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- Oct 2009to May 2012
- 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
- HIV-1 infected adults (=/+18 years old).
- Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
- Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
- Patient having at least one of the following conditions:
- Antiretroviral-related gastrointestinal disturbances, or
- Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or
Show all 11Show fewer
- Any toxicity drug related.
- Nadir CD4 cell count > 350 cells/mm3.
- Absence of resistance mutations in the RT or PR by (TrugeneTM)
- Good treatment adherence.
- Voluntary written informed consent.
Who cannot join
- Virologic failure to a previous antiretroviral regimen.
- Any antiretroviral resistance mutation in a previous resistance test.
- Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Barcelona, 08916
Lluita contra la Sida Foundation, HIV Unit
Badalona, Barcelona, 08916
About this study
Official title: Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
Read the detailed description
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).
Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) 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, HIV Infections
- Being tested
- maraviroc, control group
- Keywords
- Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocDrug
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
control groupDrug
HAART regimen including 2 NRTI/NtRTIs plus one of the following :
- 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir)
- or ATV/unboosted (in a regimen without tenofovir)
- or 1 NNRTI (nevirapine or efavirenz).
| Study group | Role | What they receive |
|---|---|---|
| to switch from the NNRTI/PI to maraviroc | Experimental | to switch from the NNRTI/PI to maraviroc Receives: Drug: maraviroc |
| to continue with the same approach | Active comparator | to continue with the same approach Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Measured: 48 weeks
Secondary outcomes (10)
Time to virological failure
Measured: 48 weeks
Administration of lipid-lowering drugs
Measured: 48 weeks
Changes in the SCORE equation
Measured: 48 weeks
CD4 / CD8 cell counts
Measured: 48 weeks
Antiretroviral resistance and viral tropism
Measured: 48 weeks
Patients who withdraw
Measured: 48 weeks
Total cholesterol
Total cholesterol levels
Measured: 48 weeks
HDL-cholesterol
HDL-cholesterol levels
Measured: 48 weeks
LDL-cholesterol
LDL-cholesterol levels
Measured: 48 weeks
Triglyceride
Triglyceride levels
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionMay 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sílvia Gel, Germans Trias i Pujol Hospital
- Investigators
- Eugènia Negredo, MD,PhD, Principal investigator, Lluita contra la Sida Foundation, HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966329
- Sponsor's protocol ID
- MARAVI-SWITCH
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2009
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonjoch A, Pou C, Perez-Alvarez N, Bellido R, Casadella M, Puig J, Noguera-Julian M, Clotet B, Negredo E, Paredes R. Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: a pilot, prospective, randomized clinical trial. J Antimicrob Chemother. 2013 Jun;68(6):1382-7. doi: 10.1093/jac/dks539. Epub 2013 Jan 25.
PubMed 23354282
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression
- ClinicalTrials.gov ID
- NCT00966329
- Acronym / sponsor ID
- MARAVI-SWITCH
- Conditions
- HIV, HIV Infections
- Keywords
- Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Aug 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.
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
Detailed description
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).
Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) 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 |
|---|---|---|
| to switch from the NNRTI/PI to maraviroc | Experimental | Drug: maravirocto switch from the NNRTI/PI to maraviroc |
| to continue with the same approach | Active comparator | Drug: control groupto continue with the same approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV-1 infected adults (=/+18 years old).
- Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
- Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
- Patient having at least one of the following conditions:
- Nadir CD4 cell count > 350 cells/mm3.
Key exclusion criteria (5 listed)
- Virologic failure to a previous antiretroviral regimen.
- Any antiretroviral resistance mutation in a previous resistance test.
- Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
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 |
|---|---|---|
| maravirocHAART regimen including 2 NRTI/NtRTIs plus maraviroc | Drug | to switch from the NNRTI/PI to maraviroc |
| control groupHAART regimen including 2 NRTI/NtRTIs plus one of the following : * 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) * or ATV/unboosted (in a regimen without tenofovir) * or 1 NNRTI (nevirapine or efavirenz). | Drug | to continue with the same approach |
Primary outcome
Viral load
Time frame: 48 weeks
10 secondary outcomes
Time to virological failure
Time frame: 48 weeks
Administration of lipid-lowering drugs
Time frame: 48 weeks
Changes in the SCORE equation
Time frame: 48 weeks
CD4 / CD8 cell counts
Time frame: 48 weeks
Antiretroviral resistance and viral tropism
Time frame: 48 weeks
Patients who withdraw
Time frame: 48 weeks
Total cholesterol
Time frame: 48 weeks
HDL-cholesterol
Time frame: 48 weeks
LDL-cholesterol
Time frame: 48 weeks
Triglyceride
Time frame: 48 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 24 Jan 2013.
- Derived from this study: PubMed 23354282Bonjoch A, Pou C, Perez-Alvarez N, Bellido R, Casadella M, Puig J, Noguera-Julian M, Clotet B, Negredo E, Paredes R. Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: a pilot, prospective, randomized clinical trial. J Antimicrob Chemother. 2013 Jun;68(6):1382-7. doi: 10.1093/jac/dks539. Epub 2013 Jan 25.
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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.
Eugènia Negredo, MD,PhD principal investigator
Lluita contra la Sida Foundation, HIV Unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing maraviroc in people with HIV and HIV Infections, run by Germans Trias i Pujol Hospital at 3 sites 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 11 inclusion and 5 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Viral load (time frame: 48 weeks). 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 NCT00966329, 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 24 Jan 2013.