HealthyPhase 4NCT00666705

A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

A Phase 4 study testing Maraviroc and Raltegravir in people with Healthy, run by ViiV Healthcare at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Maraviroc and Raltegravir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Mar 2008
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and/or female subjects between 18 and 55 years of age.

Who cannot join

Evidence or history of clinically significant disease or clinical findings at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.

Read the detailed description

Drug interaction study

Conditions: Healthy
Being tested: Maraviroc, Raltegravir
Keywords: maraviroc, raltegravir, drug interaction study, healthy volunteers

What participants receive

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

MaravirocDrug
Also called Selzentry, Celsentri
300 milligrams(mg) every 12 hours Days 6-11
MaravirocDrug
Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
RaltegravirDrug
Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
RaltegravirDrug
400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5

Study groups in NCT00666705
Study group	Role	What they receive
Maraviroc alone	Experimental	Not described Receives: Drug: Maraviroc
Maraviroc + Raltegravir	Experimental	Not described Receives: Drug: Maraviroc; Drug: Raltegravir
Raltegravir alone	Experimental	Not described Receives: Drug: Raltegravir

What is being measured

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

Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).
Measured: Days 11 and 14
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.
Measured: Days 11 and 14
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).
Measured: Days 3 and 14
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.
Measured: Days 3 and 14

Timeline

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

Feb 2008Mar 2008

First posted25 Apr 2008 (estimated)
Study startFeb 2008
Primary completionMar 2008
Study completionMar 2008

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.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe 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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666705
Sponsor's protocol ID: A4001082
Status last verified: Jan 2013
First submitted: 23 Apr 2008
Last updated: 25 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
ClinicalTrials.gov ID: NCT00666705
Acronym / sponsor ID: A4001082
Conditions: Healthy
Keywords: maraviroc, raltegravir, drug interaction study, healthy volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Feb 2008
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 25 Apr 2008 (estimated)
Results: Posted 4 Jun 2009

Clinical summary

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

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.

Detailed description

Drug interaction study

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Maraviroc alone	Experimental	Drug: Maraviroc
Maraviroc + Raltegravir	Experimental	Drug: Maraviroc, Drug: Raltegravir
Raltegravir alone	Experimental	Drug: Raltegravir

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and/or female subjects between 18 and 55 years of age.

Key exclusion criteria (1 listed)

Evidence or history of clinically significant disease or clinical findings at screening

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
MaravirocAlso: Selzentry, Celsentri300 milligrams(mg) every 12 hours Days 6-11	Drug	Maraviroc alone
MaravirocDays 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)	Drug	Maraviroc + Raltegravir
RaltegravirDays 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)	Drug	Maraviroc + Raltegravir
Raltegravir400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5	Drug	Raltegravir alone

Primary outcome

Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
Time frame: Days 11 and 14
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
Time frame: Days 11 and 14
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
Time frame: Days 3 and 14
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
Time frame: Days 3 and 14
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.

Results and safety

Results posted to the registry on 4 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maraviroc / Raltegravir (Alone and Co-administered)	18	17

Primary outcome: Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

Time frame: Days 11 and 14. Mean (Standard Deviation). Unit: ng.hr/mL

Measure	Maraviroc + Raltegravir (Test) n = 17	Maraviroc (Reference) n = 17
Value	2551.9 (786.68)	2971.6 (841.65)

Maraviroc + Raltegravir (Test) vs Maraviroc (Reference): Ratio (percent): 85.76 (90% CI 79.89 to 92.07), Mixed Models Analysis

Population analysed: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.

Primary outcome: Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)

Time frame: Days 11 and 14. Mean (Standard Deviation). Unit: ng/mL

Measure	Maraviroc + Raltegravir (Test) n = 17	Maraviroc (Reference) n = 17
Value	691.6 (322.24)	851.4 (349.38)

Maraviroc + Raltegravir (Test) vs Maraviroc (Reference): Ratio (percent): 79.48 (90% CI 67.19 to 94.02), Mixed Models Analysis

Primary outcome: Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

Time frame: Days 3 and 14. Mean (Standard Deviation). Unit: ng.hr/mL

Measure	Maraviroc + Raltegravir (Test) n = 17	Raltegravir (Reference) n = 18
Value	6287.5 (3979.30)	9122.4 (5311.34)

Maraviroc + Raltegravir (Test) vs Raltegravir (Reference): Ratio (percent): 63.25 (90% CI 44.27 to 90.39), Mixed Models Analysis

Primary outcome: Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)

Time frame: Days 3 and 14. Mean (Standard Deviation). Unit: ng/mL

Measure	Maraviroc + Raltegravir (Test) n = 17	Raltegravir (Reference) n = 18
Value	2169.6 (1570.58)	3026.6 (2030.15)

Maraviroc + Raltegravir (Test) vs Raltegravir (Reference): Ratio (percent): 66.77 (90% CI 41.22 to 108.15), Mixed Models Analysis

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc	0 of 18 (0%)	4 of ?	Not reported
Maraviroc + Raltegravir	0 of 17 (0%)	4 of ?	Not reported
Raltegravir	0 of 18 (0%)	3 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Healthy

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

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.

Pfizer CT.gov Call Center study director

Pfizer

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 Maraviroc and Raltegravir in people with Healthy, run by ViiV Healthcare at 1 site in United States.

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 1 inclusion and 1 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 25 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 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 4 Jun 2009). 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?

Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ) (time frame: Days 11 and 14). The study lists 4 primary outcomes in all. 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 NCT00666705.

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 25 Jan 2013.