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CCR5 Antagonist

Maraviroc for HIV/AIDS

Phase 2
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 years
Awards & highlights

Study Summary

This trial will study the effects of the drug maraviroc in HIV-1 infected children and adolescents, in order to determine a safe dosage schedule.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve at Steady State (AUCtau)
Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)
Maraviroc
+2 more
Secondary outcome measures
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48
Change From Baseline in HIV-1 RNA (Log10 Copies/mL)
Change From Baseline in HIV-1 RNA (Original)
+11 more

Side effects data

From 2008 Phase 4 trial • 18 Patients • NCT00666705
6%
Folliculitis
6%
Constipation
6%
Peripheral neurophathy
6%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maraviroc
Maraviroc + Raltegravir
Raltegravir

Trial Design

1Treatment groups
Experimental Treatment
Group I: MaravirocExperimental Treatment1 Intervention
Subjects will be stratified by age and formulation into one of the following cohorts: Cohort 1: ≥2-<6 years of age, maraviroc liquid formulation; Cohort 2: ≥6-<12 years of age, maraviroc tablet formulation; Cohort 3: ≥6-<12 years of age, maraviroc liquid formulation and Cohort 4: ≥12-<18 years of age, maraviroc tablet formulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maraviroc
FDA approved

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,783 Total Patients Enrolled
ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
468,476 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,092,951 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of a patient factor into their eligibility for this experiment?

"This medical trial seeks to enroll participants aged 2-18 years old. Altogether, there are 150 trials involving minors and 471 targeting adults beyond the age of 65."

Answered by AI

Is this research pioneering a new approach to the field?

"Presently, 5 active studies for Maraviroc are taking place in 27 cities and 12 countries. The first of these trials began in 2009 under the sponsorship of ViiV Healthcare; this phase 2 study recruited 103 participants before it was completed. Since then, another 99 such undertakings have been launched."

Answered by AI

Do I meet the prerequisites to participate in this investigation?

"To qualify for this trial, participants must suffer from acquired immunodeficiency syndrome and be between the age of 2 and 18. To fulfil the requirements of this study, 103 patients are required to take part in it."

Answered by AI

What is the approximate sample size of this research endeavor?

"This clinical trial is not presently taking on any new patients. This study was initially published in April 2009 and underwent its most recent update in April of 2020. If you are seeking other trials, there are currently 636 studies actively recruiting participants with acquired immunodeficiency syndrome and 5 studies for Maraviroc that require participants."

Answered by AI

Can you elucidate the key goals of this investigation?

"This clinical trial will primarily evaluate the Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (AEs) at Weeks 2 and 48 post-dose. Secondary objectives include assessing the Change From Baseline in Percentage (%) of CD4+ Cells between Weeks 24 and 48, Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) or Protease Inhibitor (PI) Resistance Associated Mutations (RAMs), as well as Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration from Baseline to Week 24/48."

Answered by AI

Are there various research centers executing this inquiry in town?

"As of right now, 18 clinical sites are taking on participants for this trial. Locations span from Jacksonville to Atlanta and Wilmington as well as other places in the United States. It is recommended that patients choose a location near them in order to reduce their need for travel if they take part in the study."

Answered by AI

How secure is the usage of Maraviroc among humans?

"Taking into account the fact that this trial is at Phase 2, our analysts have concluded that Maraviroc can be considered moderately safe and assigned it a score of 2."

Answered by AI

Are there any precedents of research conducted on Maraviroc?

"Maraviroc was initially explored in 2009 at IRCCS Ospedale Pediatrico Bambino Gesu, with 99 studies having been completed since then. Currently there are 5 ongoing trials occurring mainly out of Jacksonville, Florida."

Answered by AI

Is the recruitment process for this study currently underway?

"Unfortunately, clinicaltrials.gov reveals that recruitment for this particular medical trial has concluded as of April 17th 2020 - the last time it was updated. Although no longer active, 641 other studies are actively recruiting patients at this moment in time."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Children's Medical Center of Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’ve used 2 prescriptions prior to and would like to see how effect this new medication will be on my current condition.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is this trial?
PatientReceived no prior treatments
~6 spots leftby Apr 2025