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

NCT00791700 | Unknown Phase 2 Results DMC FDA Drug

• 2 other identifiers: A40010312008-006873-33
• Study Type: interventional
• Target: 103
• Locations: 9 countries
• Sites: 41

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.

Conditions

Human Immunodeficiency Virus

Keywords

Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)

  Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.

  Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

• Area Under the Curve at Steady State (AUCtau)

  AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.

  Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

• Time to Reach Maximum Plasma Concentration (Tmax)

  Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

• Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)

  Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.

  Baseline up to 5 years

• Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug

  The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.

  Baseline up to 5 years

Secondary Outcomes (14)

• Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach

  Week 24 and Week 48 post-treatment

• Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach

  Week 24 and Week 48 post-treatment

• Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach

  Week 24 and Week 48 post-treatment

• Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach

  Week 24 and Week 48 post-treatment

• 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

  Week 48

Study Arms (1)

Maraviroc

EXPERIMENTAL

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.

Drug: Maraviroc

Interventions

Maraviroc DRUG

Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.

Also known as: Selzentry

Maraviroc

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (41)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Rainbow Center at University of Florida Health

Jacksonville, Florida, 32209, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Grady Health System, IDP

Atlanta, Georgia, 30308, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Pediatric Infectious Disease Clinic

Jackson, Mississippi, 39213, United States

Location

Batson Specialty Clinic

Jackson, Mississippi, 39216, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Cincinnati Center for Clinical Research

Cincinnati, Ohio, 45206, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

UT Physician

Houston, Texas, 77030, United States

Location

VCU Health System Clinical Research Services

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Instituto de Infectologia Emilio Ribas

São Paulo, São Paulo, 01246-900, Brazil

Location

Condomínio Edifício Parque Paulista

São Paulo, 01416-000, Brazil

Location

Clinica Pediatrica Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Farmacia Interna

Padua, 35128, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive

Torino, 10126, Italy

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City, 06720, Mexico

Location

Centro Hospitalar Universitario do Algarve, EPE

Faro, 8000-386, Portugal

Location

Centro Hospitalar de Lisboa Central, EPE

Lisbon, 1169-045, Portugal

Location

Centro Hospitalar de Lisboa Norte, EPE

Lisbon, 1649-035, Portugal

Location

Hospital S. João, E.P.E

Porto, 4202-451, Portugal

Location

Hospital San Juan Research Unit

San Juan, PR, 00935, Puerto Rico

Location

Iatros International

Bloemfontein, Free State, 9301, South Africa

Location

Lakeview Hospital

Benoni, Gauteng, 1501, South Africa

Location

Dr George Mukhari Hospital

Ga-Rankuwa, Gauteng, 0208, South Africa

Location

Dr. Jan Fourie Medical Centre

Dundee, KwaZulu-Natal, 3000, South Africa

Location

Embassy Drive Medical Center

Pretoria, 0083, South Africa

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain, 08950, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Department of Pediatric, Faculty of Medicine, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Muang, Chiang Mai, 50200, Thailand

Location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

Bangkok, 10330, Thailand

Location

Department of Pediatrics, Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: April 22, 2009
• Primary Completion: April 14, 2015
• Study Completion: June 30, 2023
• Last Updated: April 28, 2020
• Results First Posted: February 25, 2016

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (2); PT (4); ZA (5); ME (1); PR (1); TH (4); US (18); IT (4); ES (2)