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CompletedNCT00666705Updated Jan 25, 2013Results posted

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

A Phase 4 interventional study of Maraviroc and Maraviroc in Healthy, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-25.

Sponsored by ViiV Healthcare · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

Drug interaction study

02

Conditions studied

  • Healthy

Keywords

  • maraviroc
  • raltegravir
  • drug interaction study
  • healthy volunteers
03

In context

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Evidence or history of clinically significant disease or clinical findings at screening
05

Study design

Phase
Phase 4
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Maraviroc alone

    Drug: Maraviroc

  • Experimental
    Maraviroc + Raltegravir

    Drug: Maraviroc · Drug: Raltegravir

  • Experimental
    Raltegravir alone

    Drug: Raltegravir

Interventions

  • DrugMaraviroc

    300 milligrams(mg) every 12 hours Days 6-11

    Also known as: Selzentry, Celsentri

  • DrugMaraviroc

    Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)

  • DrugRaltegravir

    Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)

  • DrugRaltegravir

    400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Days 11 and 14

  2. 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.

    Time frame: Days 11 and 14

  3. 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).

    Time frame: Days 3 and 14

  4. 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.

    Time frame: Days 3 and 14

Other outcomes

  1. Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)

    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 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). C12 is the 12-hour trough concentration.

    Time frame: Days 11 and 14

  2. Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)

    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.

    Time frame: Days 3 and 14

07

Results

Posted Jun 4, 2009

Participant flow

One site in the United States

Participant flow — Overall Study
MilestoneMaraviroc / Raltegravir (Alone and Co-administered)
Started18
Raltegravir alone (days 1 - 3)18
Washout (days 4 - 5)18
Maraviroc alone (days 6 - 11)18
Raltegravir + maraviroc (days 12 - 14)17
Completed17
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryMaraviroc 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).

Time frame:
Days 11 and 14
Reported as:
Mean · ng.hr/mL
Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
ng.hr/mLMaraviroc + Raltegravir (Test)Maraviroc (Reference)
Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)2551.9 ± 786.682971.6 ± 841.65
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Maraviroc (Reference) · Mixed Models Analysis · Ratio (percent): 85.76 · 90% CI 79.89 to 92.07Ratio (percent) (Test/Reference) of Adjusted Geometric Means
PrimaryMaraviroc 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.

Time frame:
Days 11 and 14
Reported as:
Mean · ng/mL
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
ng/mLMaraviroc + Raltegravir (Test)Maraviroc (Reference)
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)691.6 ± 322.24851.4 ± 349.38
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Maraviroc (Reference) · Mixed Models Analysis · Ratio (percent): 79.48 · 90% CI 67.19 to 94.02Ratio (percent) (Test/Reference) of Adjusted Geometric Means
PrimaryRaltegravir 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).

Time frame:
Days 3 and 14
Reported as:
Mean · ng.hr/mL
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
ng.hr/mLMaraviroc + Raltegravir (Test)Raltegravir (Reference)
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)6287.5 ± 3979.309122.4 ± 5311.34
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Raltegravir (Reference) · Mixed Models Analysis · Ratio (percent): 63.25 · 90% CI 44.27 to 90.39Ratio (percent) (Test/Reference) of Adjusted Geometric Means
Other pre-specifiedMaraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)

Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 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). C12 is the 12-hour trough concentration.

Time frame:
Days 11 and 14
Reported as:
Mean · ng/mL
Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)
ng/mLMaraviroc + Raltegravir (Test)Maraviroc (Reference)
Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)48.34 ± 13.7053.36 ± 14.03
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Maraviroc (Reference) · Mixed Models Analysis · Ratio (percent): 90.33 · 90% CI 85.28 to 95.68Ratio (percent) (Test/Reference) of Adjusted Geometric Means
PrimaryRaltegravir 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.

Time frame:
Days 3 and 14
Reported as:
Mean · ng/mL
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
ng/mLMaraviroc + Raltegravir (Test)Raltegravir (Reference)
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)2169.6 ± 1570.583026.6 ± 2030.15
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Raltegravir (Reference) · Mixed Models Analysis · Ratio (percent): 66.77 · 90% CI 41.22 to 108.15Ratio (percent) (Test/Reference) of Adjusted Geometric Means
Other pre-specifiedRaltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)

Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.

Time frame:
Days 3 and 14
Reported as:
Mean · ng/mL
Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)
ng/mLMaraviroc + Raltegravir (Test)Raltegravir (Reference)
Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)51.16 ± 22.6473.69 ± 36.21
Statistical analysis
  • Maraviroc + Raltegravir (Test) vs Raltegravir (Reference) · Mixed Models Analysis · Ratio (percent): 72.42 · 90% CI 57.82 to 90.71Ratio (percent) (Test/Reference) of Adjusted Geometric Means

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Maraviroc—0/18 (0%)—
Maraviroc + Raltegravir—0/17 (0%)—
Raltegravir—0/18 (0%)—
Most frequent other events
Most frequent other events
EventMaravirocMaraviroc + RaltegravirRaltegravir
HeadacheNervous system disorders0/181/172/18
DyspepsiaGastrointestinal disorders0/181/170/18
Back painMusculoskeletal and connective tissue disorders0/181/170/18
Peripheral neurophathyNervous system disorders1/181/171/18
SomnolenceNervous system disorders1/181/170/18
ConstipationGastrointestinal disorders1/180/170/18
FolliculitisInfections and infestations1/180/171/18

Baseline characteristics

Age Continuous
Age Continuous(years)Maraviroc / Raltegravir (Alone and Co-administered)
Mean36.3 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)Maraviroc / Raltegravir (Alone and Co-administered)
Female2
Male16
08

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00666705
Lead sponsor
ViiV Healthcare
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Apr 25, 2008
Start date
Feb 2008
Primary completion
Mar 2008
Completion
Mar 2008
Results posted
Jun 4, 2009
Last update
Jan 25, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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