Clinical trial NCT00791700: An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
Official title: AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC, SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2 - <18 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
Keywords: Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-11-14
Enrollment: 103
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL

Exclusion Criteria:

* X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay
* Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs)
* Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase;
* Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST \< 2.5 X ULN; No symptoms other than jaundice or icterus.
* Other laboratory values ≥Grade 3, must be reviewed by Pfizer.

Primary outcomes:
measure: Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)
timeFrame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
measure: Area Under the Curve at Steady State (AUCtau)
timeFrame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
measure: Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)
timeFrame: Baseline up to 5 years
measure: Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach
timeFrame: Week 24 and Week 48 post-treatment
measure: Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach
timeFrame: Week 24 and Week 48 post-treatment
measure: Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach
timeFrame: Week 24 and Week 48 post-treatment
measure: Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach
timeFrame: Week 24 and Week 48 post-treatment
measure: Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48
timeFrame: Week 48
measure: Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48
timeFrame: Baseline to Week 24, Week 48 post-treatment
measure: Change From Baseline in HIV-1 RNA (Original)
timeFrame: Baseline, Week 24, Week 48 post-treatment
measure: Change From Baseline in HIV-1 RNA (Log10 Copies/mL)
timeFrame: Baseline, Week 24, Week 48 post-treatment
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48
timeFrame: Baseline, Week 24, Week 48 post-treatment
measure: Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48
timeFrame: Baseline, Week 24 and Week 48 post-treatment
measure: Number of Participants With Protocol Defined Virologic Failure
timeFrame: Week 48
measure: Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48
timeFrame: Screening to Week 48
measure: Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF
timeFrame: 48 weeks
measure: Percentage of Participants With Optimized Background Treatment Susceptibility Scores
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Rainbow Center at University of Florida Health
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Grady Health System, IDP
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Jackson
country: United States
facility: Pediatric Infectious Disease Clinic
state: Mississippi
city: Jackson
country: United States
facility: Batson Specialty Clinic
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Cincinnati
country: United States
facility: Cincinnati Center for Clinical Research
state: Ohio
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: UT Physician
state: Texas
city: Richmond
country: United States
facility: VCU Health System Clinical Research Services
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: São Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas
state: SP
city: São Paulo
country: Brazil
facility: Condomínio Edifício Parque Paulista
city: Padova
country: Italy
facility: Clinica Pediatrica Azienda Ospedaliera di Padova
city: Padova
country: Italy
facility: Farmacia Interna
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: Torino
country: Italy
facility: Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive
city: Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: DF
city: Faro
country: Portugal
facility: Centro Hospitalar Universitario do Algarve, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE
city: Porto
country: Portugal
facility: Hospital S. João, E.P.E
city: San Juan
country: Puerto Rico
facility: Hospital San Juan Research Unit
city: Bloemfontein
country: South Africa
facility: Iatros International
state: FREE State
city: Benoni
country: South Africa
facility: Lakeview Hospital
state: Gauteng
city: Ga-Rankuwa
country: South Africa
facility: Dr George Mukhari Hospital
state: Gauteng
city: Dundee
country: South Africa
facility: Dr. Jan Fourie Medical Centre
state: Kwazulu-natal
city: Pretoria
country: South Africa
facility: Embassy Drive Medical Center
city: Esplugues De Llobregat, Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Muang
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Chiang Mai University
state: Chiang MAI
city: Muang
country: Thailand
facility: Department of Pediatric, Faculty of Medicine, Khon Kaen University
state: Khon Kaen
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Siriraj Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: