HIV InfectionPhase 3NCT03708861
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
A Phase 3 study testing maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD) in people with HIV Infection, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years;
- confirmed HIV-antibodies positivity;
- signed informed consent;
- HIV-RNA <20 cp/ml for the last 24 months;
- no virological failures to PI regimens;
- no major PI resistance associated mutations;
- genotypic tropism for CCR5 co-receptor.
Who cannot join
- active opportunistic infections or neoplasms;
- need for drugs with known drug-drug interactions with included drugs;
- liver cirrhosis;
- any evidence of tropism for CXCR4 or dual infection;
- pregnancy;
- self-reported adherence<90%;
- HBsAg positivity;
- detectable HCV RNA.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.
Read the detailed description
The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.
- Conditions
- HIV Infection
- Being tested
- maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
- Keywords
- maraviroc, atazanavir, ritonavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)Drug
Also called CELSENTRI, REYATAZ, NORVIR
Phase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD).
Phase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD)
| Study group | Role | What they receive |
|---|---|---|
| MVC + ATV/r | Experimental | maraviroc (300 mg tablet, 300 mg per day every 24 hours) + atazanavir/ritonavir (300 and 200 mg capsule, 300 and 200 mg per day every 24 hours / 100 mg capsule, 100 mg per day every 24 hours) Receives: Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
Number of participants with maraviroc Ctrough>50ng/ml
Measured: within the first 16 weeks after switch
Secondary outcomes (7)
viral suppression evaluation
Number of participants with HIV-RNA<20 cp/ml
Measured: week 60
CD4 count evaluation
Changes in CD4+ count
Measured: week 60
bone density evaluation
Changes in bone mineral density (DEXA femur and spine)
Measured: week 60
bone metabolism markers evaluation
Changes in bone metabolism markers (bALP and vitamin D, PTH)
Measured: week 60
glomerular and tubular renal function evaluation
Changes in proteinuria, glycosuria, phosphaturia and GFR;
Measured: week 60
lipid metabolism markers evaluation
changes in total, HDL, LDL cholesterol and triglycerides
Measured: week 60
bilirubin evaluation
changes in total bilirubin levels
Measured: week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Perri, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708861
- Sponsor's protocol ID
- MARAT
- Other IDs
- 2014-004692-22, 2014
- Status last verified
- Apr 2019
- First submitted
- 14 Oct 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
- ClinicalTrials.gov ID
- NCT03708861
- Acronym / sponsor ID
- MARAT
- Conditions
- HIV Infection
- Keywords
- maraviroc, atazanavir, ritonavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Oct 2018 (actual)
- 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.
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.
Detailed description
The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MVC + ATV/r | Experimental | Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)maraviroc (300 mg tablet, 300 mg per day every 24 hours) + atazanavir/ritonavir (300 and 200 mg capsule, 300 and 200 mg per day every 24 hours / 100 mg capsule, 100 mg per day every 24 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age>18 years;
- confirmed HIV-antibodies positivity;
- signed informed consent;
- HIV-RNA <20 cp/ml for the last 24 months;
- no virological failures to PI regimens;
Key exclusion criteria (8 listed)
- active opportunistic infections or neoplasms;
- need for drugs with known drug-drug interactions with included drugs;
- liver cirrhosis;
- any evidence of tropism for CXCR4 or dual infection;
- pregnancy;
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 |
|---|---|---|
| maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)Also: CELSENTRI, REYATAZ, NORVIRPhase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD). Phase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD) | Drug | MVC + ATV/r |
Primary outcome
maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
Time frame: within the first 16 weeks after switch
Number of participants with maraviroc Ctrough>50ng/ml
7 secondary outcomes
viral suppression evaluation
Time frame: week 60
CD4 count evaluation
Time frame: week 60
bone density evaluation
Time frame: week 60
bone metabolism markers evaluation
Time frame: week 60
glomerular and tubular renal function evaluation
Time frame: week 60
lipid metabolism markers evaluation
Time frame: week 60
bilirubin evaluation
Time frame: week 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 3 study testing maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD) in people with HIV Infection, run by University of Turin, Italy at 1 site in Italy.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Nov 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation (time frame: within the first 16 weeks after switch). 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 6 Nov 2020.