HIVPhase 4NCT02442700

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

A Phase 4 study testing pitavastatin in people with HIV and Dyslipidemia, run by Ramathibodi Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, Dyslipidemia
What is being tested?: pitavastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: No sites listed yet
Study dates: May 2014to Jan 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

aged ≥18 years
able to provide informed consent
had confirmed HIV infection
on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization
patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization

Who cannot join

had the history of pitavastatin and/or the constituent of the drugs allergy
known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment
abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients
pregnancy or breastfeeding
on cyclosporine which had major drug interactions with pitavastatin
patients who denied to join the study

About this study

Official title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study

Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.

Conditions: HIV, Dyslipidemia
Being tested: pitavastatin, placebo
Keywords: HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pitavastatinDrug
Also called Livalo
Treatment A = administration pitavastatin for 12 weeks
placeboDrug
Treatment B = administration placebo for 12 weeks

Study groups in NCT02442700
Study group	Role	What they receive
Treatment sequence A, B	Experimental	Treatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks Receives: Drug: pitavastatin; Drug: placebo
Treatment sequence B, A	Experimental	Treatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks Receives: Drug: pitavastatin; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.
Measured: 12 weeks

Secondary outcomes (1)

Safety of Pitavastatin in HIV-infected Patients
Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.
Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jan 2015

First posted13 May 2015 (estimated)
Study startMay 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Crossover
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02442700
Sponsor's protocol ID: Ramathibodi Hospital 01-57-18
Status last verified: Aug 2016
First submitted: 25 Feb 2015
Last updated: 10 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wongprikorn A, Sukasem C, Puangpetch A, Numthavej P, Thakkinstian A, Kiertiburanakul S. Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study. PLoS One. 2016 Jun 15;11(6):e0157531. doi: 10.1371/journal.pone.0157531. eCollection 2016.
PubMed 27304841

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study
ClinicalTrials.gov ID: NCT02442700
Acronym / sponsor ID: Ramathibodi Hospital 01-57-18
Conditions: HIV, Dyslipidemia
Keywords: HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Ramathibodi HospitalUniversity, hospital or other
Study start: May 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 13 May 2015 (estimated)
Results: Posted 10 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment sequence A, B	Experimental	Drug: pitavastatin, Drug: placeboTreatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
Treatment sequence B, A	Experimental	Drug: pitavastatin, Drug: placeboTreatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

aged ≥18 years
able to provide informed consent
had confirmed HIV infection
on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization
patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization

Key exclusion criteria (6 listed)

had the history of pitavastatin and/or the constituent of the drugs allergy
known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment
abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients
pregnancy or breastfeeding
on cyclosporine which had major drug interactions with pitavastatin

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
pitavastatinAlso: LivaloTreatment A = administration pitavastatin for 12 weeks	Drug	Treatment sequence A, B, Treatment sequence B, A
placeboTreatment B = administration placebo for 12 weeks	Drug	Treatment sequence A, B, Treatment sequence B, A

Primary outcome

Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Time frame: 12 weeks
Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.

1 secondary outcome

Safety of Pitavastatin in HIV-infected Patients
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A, B	12	12
Treatment B, A	12	12

Primary outcome: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Treatment A n = 24	Treatment B n = 24
TC at baseline	239.9 (220.2 to 259.6)	257.6 (237.9 to 277.3)
TG at baseline	282 (123.9 to 440)	350 (191.9 to 508)
LDL at baseline	144.7 (131.9 to 157.4)	146.3 (133.6 to 159.1)
HDL at baseline	43 (38.1 to 47.9)	44.8 (39.9 to 49.7)
TC at 4 weeks after treatment	201.3 (181.5 to 221)	246.6 (226.9 to 266.3)
TG at 4 weeks after treatment	246.5 (88.4 to 404.5)	292.5 (134.4 to 450.5)
LDL at 4 weeks after treatment	111.6 (98.8 to 124.4)	142.5 (129.7 to 155.3)
HDL at 4 weeks after treatment	43.5 (38.6 to 48.3)	43.5 (38.7 to 48.4)

Treatment A vs Treatment B: p <0.05, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 24 (0%)	0 of 24 (0%)	Not reported
Treatment B	0 of 24 (0%)	0 of 24 (0%)	Not reported

Limitations and caveats (from the sponsor): LImitation of this study is we did not adjust pitavastatin dosage according to lipid profiles,thus mean value of TC could not be lower than 200 mg/dL.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27304841Wongprikorn A, Sukasem C, Puangpetch A, Numthavej P, Thakkinstian A, Kiertiburanakul S. Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study. PLoS One. 2016 Jun 15;11(6):e0157531. doi: 10.1371/journal.pone.0157531. eCollection 2016.

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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.

Asita Wongprikorn principal investigator

Ramathibodi Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pitavastatin in people with HIV and Dyslipidemia, run by Ramathibodi Hospital.

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 5 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 10 Oct 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. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (time frame: 12 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 NCT02442700, 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 10 Oct 2016.