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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.
- HIV/AIDS
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 4 trial • 18 Patients • NCT00666705Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
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