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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

Primary Purpose

Human Immunodeficiency Virus

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Maraviroc

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital Los Angeles
Children's Hospital of Orange County
Alfred I. DuPont Hospital for Children
Children's National Medical Center
Rainbow Center at University of Florida Health
University of Miami Miller School of Medicine
University of South Florida
Grady Health System, IDP
Children's Healthcare of Atlanta
Pediatric Infectious Disease Clinic
Batson Specialty Clinic
University of Mississippi
Cincinnati Center for Clinical Research
Children's Medical Center of Dallas
Children's Memorial Hermann Hospital
UT Physician
VCU Health System Clinical Research Services
Virginia Commonwealth University
Instituto de Infectologia Emilio Ribas
Condomínio Edifício Parque Paulista
Clinica Pediatrica Azienda Ospedaliera di Padova
Farmacia Interna
IRCCS Ospedale Pediatrico Bambino Gesu
Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive
Hospital Infantil de Mexico Federico Gomez
Centro Hospitalar Universitario do Algarve, EPE
Centro Hospitalar de Lisboa Central, EPE
Centro Hospitalar de Lisboa Norte, EPE
Hospital S. João, E.P.E
Hospital San Juan Research Unit
Iatros International
Lakeview Hospital
Dr George Mukhari Hospital
Dr. Jan Fourie Medical Centre
Embassy Drive Medical Center
Hospital Sant Joan de Deu
Hospital Universitario 12 de Octubre
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Department of Pediatric, Faculty of Medicine, Khon Kaen University
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Time to Reach Maximum Plasma Concentration (Tmax)

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.

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.

Secondary Outcome Measures

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

The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.

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

The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.

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

Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].

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

Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].

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

TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.

Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48

Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.

Change From Baseline in HIV-1 RNA (Original)

Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.

Change From Baseline in HIV-1 RNA (Log10 Copies/mL)

Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48

Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.

Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48

Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.

Number of Participants With Protocol Defined Virologic Failure

The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days.

Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48

Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.

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

Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.

Percentage of Participants With Optimized Background Treatment Susceptibility Scores

Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.

Full Information

NCT ID

NCT00791700

First Posted

November 12, 2008

Last Updated

April 17, 2020

Sponsor

ViiV Healthcare

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00791700

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 22, 2009 (Actual)

Primary Completion Date

April 14, 2015 (Actual)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maraviroc

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Other Intervention Name(s)

Selzentry

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Area Under the Curve at Steady State (AUCtau)

Description

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.

Time Frame

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

Title

Time to Reach Maximum Plasma Concentration (Tmax)

Time Frame

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

Title

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

Description

Time Frame

Baseline up to 5 years

Title

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

Description

Time Frame

Baseline up to 5 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 24 and Week 48 post-treatment

Title

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

Description

Time Frame

Week 24 and Week 48 post-treatment

Title

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

Description

Time Frame

Week 24 and Week 48 post-treatment

Title

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

Description

Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].

Time Frame

Week 24 and Week 48 post-treatment

Title

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

Description

TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.

Time Frame

Week 48

Title

Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48

Description

Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.

Time Frame

Baseline to Week 24, Week 48 post-treatment

Title

Change From Baseline in HIV-1 RNA (Original)

Description

Time Frame

Baseline, Week 24, Week 48 post-treatment

Title

Change From Baseline in HIV-1 RNA (Log10 Copies/mL)

Description

Time Frame

Baseline, Week 24, Week 48 post-treatment

Title

Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48

Description

Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.

Time Frame

Baseline, Week 24, Week 48 post-treatment

Title

Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48

Description

Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.

Time Frame

Baseline, Week 24 and Week 48 post-treatment

Title

Number of Participants With Protocol Defined Virologic Failure

Description

Time Frame

Week 48

Title

Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48

Description

Time Frame

Screening to Week 48

Title

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

Description

Time Frame

48 weeks

Title

Percentage of Participants With Optimized Background Treatment Susceptibility Scores

Description

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Children's Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Alfred I. DuPont Hospital for Children

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19803

Country

United States

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Rainbow Center at University of Florida Health

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

University of Miami Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Grady Health System, IDP

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Children's Healthcare of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Pediatric Infectious Disease Clinic

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39213

Country

United States

Facility Name

Batson Specialty Clinic

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

University of Mississippi

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Cincinnati Center for Clinical Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

Children's Medical Center of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Children's Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

UT Physician

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

VCU Health System Clinical Research Services

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Instituto de Infectologia Emilio Ribas

City

São Paulo

State/Province

ZIP/Postal Code

01246-900

Country

Brazil

Facility Name

Condomínio Edifício Parque Paulista

City

São Paulo

ZIP/Postal Code

01416-000

Country

Brazil

Facility Name

Clinica Pediatrica Azienda Ospedaliera di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Farmacia Interna

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

IRCCS Ospedale Pediatrico Bambino Gesu

City

Roma

ZIP/Postal Code

00165

Country

Italy

Facility Name

Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Hospital Infantil de Mexico Federico Gomez

City

Mexico

State/Province

ZIP/Postal Code

06720

Country

Mexico

Facility Name

Centro Hospitalar Universitario do Algarve, EPE

City

Faro

ZIP/Postal Code

8000-386

Country

Portugal

Facility Name

Centro Hospitalar de Lisboa Central, EPE

City

Lisboa

ZIP/Postal Code

1169-045

Country

Portugal

Facility Name

Centro Hospitalar de Lisboa Norte, EPE

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Hospital S. João, E.P.E

City

Porto

ZIP/Postal Code

4202-451

Country

Portugal

Facility Name

Hospital San Juan Research Unit

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Iatros International

City

Bloemfontein

State/Province

FREE State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Lakeview Hospital

City

Benoni

State/Province

Gauteng

ZIP/Postal Code

1501

Country

South Africa

Facility Name

Dr George Mukhari Hospital

City

Ga-Rankuwa

State/Province

Gauteng

ZIP/Postal Code

0208

Country

South Africa

Facility Name

Dr. Jan Fourie Medical Centre

City

Dundee

State/Province

Kwazulu-natal

ZIP/Postal Code

3000

Country

South Africa

Facility Name

Embassy Drive Medical Center

City

Pretoria

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Hospital Sant Joan de Deu

City

Esplugues De Llobregat, Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Department of Pediatrics, Faculty of Medicine, Chiang Mai University

City

Muang

State/Province

Chiang MAI

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Department of Pediatric, Faculty of Medicine, Khon Kaen University

City

Muang

State/Province

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

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

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Department of Pediatrics, Faculty of Medicine, Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001031&StudyName=An%20Open%20Label%20Pharmacokinetic%2C%20Safety%20And%20Efficacy%20Study%20Of%20Maraviroc%20In%20Combination%20With%20Background%20Therapy%20For%20The%20Treatment%20Of%20HIV-

Description

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Learn more about this trial

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

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