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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT00791700

First received: November 12, 2008

Last updated: December 21, 2016

Last verified: December 2016

History of Changes

Results First Received: October 6, 2015

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Human Immunodeficiency Virus (HIV)
Intervention:	Drug: Maraviroc

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study enrolled 103 participants at 24 sites in 8 countries.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes.

Reporting Groups

	Description
>=2 - <6 Years of Age, MVC Liquid Formulation	In cohort 1, >=2 - <6 years of age, MVC liquid formulation
>=6 - <12 Years of Age, MVC Tablet Formulation	In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
>=6 - <12 Years of Age, MVC Liquid Formulation	In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
>=12 - <18 Years of Age, MVC Tablet Formulation	In Cohort 4, >=12 - <18 years of age, MVC tablet formulation

Participant Flow: Overall Study

	>=2 - <6 Years of Age, MVC Liquid Formulation	>=6 - <12 Years of Age, MVC Tablet Formulation	>=6 - <12 Years of Age, MVC Liquid Formulation	>=12 - <18 Years of Age, MVC Tablet Formulation
STARTED	16 ^[1]	31 ^[1]	13 ^[1]	43 ^[1]
COMPLETED	12	26	9	25 ^[2]
NOT COMPLETED	4	5	4	18
Insufficient clinical response	3	4	3	13
Adverse Event	0	0	1	1
No longer willing to participate	0	1	0	1
Non-compliance with study treatment	1	0	0	2
Blood sampling not done before Stage 1	0	0	0	1

^[1]	Please note that the data presented here is Subject Discontinuations Through Week 48.
^[2]	Two participants discontinued treatment after the lower bound (days 313 and 314) of Week 48 window.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) consisted of all participants who received at least 1 dose of study drug (same as analysis population set [APS] 4).

Reporting Groups

	Description
>=2 - <6 Years of Age, MVC Liquid Formulation	In cohort 1, >=2 - <6 years of age, MVC liquid formulation
>=6 - <12 Years of Age, MVC Tablet Formulation	In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
>=6 - <12 Years of Age, MVC Liquid Formulation	In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
>=12 - <18 Years of Age, MVC Tablet Formulation	In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
Total	Total of all reporting groups

Baseline Measures

	>=2 - <6 Years of Age, MVC Liquid Formulation	>=6 - <12 Years of Age, MVC Tablet Formulation	>=6 - <12 Years of Age, MVC Liquid Formulation	>=12 - <18 Years of Age, MVC Tablet Formulation	Total
Overall Participants Analyzed [Units: Participants]	16	31	13	43	103

Age [Units: Years] Mean (Standard Deviation)	3.4 (0.9)	9.1 (1.7)	8.9 (2.0)	14.0 (1.6)	10.3 (4.1)

Gender [Units: Participants] Count of Participants
Female	5 31.3%	16 51.6%	6 46.2%	27 62.8%	54 52.4%
Male	11 68.8%	15 48.4%	7 53.8%	16 37.2%	49 47.6%

Outcome Measures

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1. Primary:

Pharmacokinetic (PK) Parameters for Participants With Data in Stage 1 Enrolled in Stage 2 – Week 48 [ Time Frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) ]

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2. Primary:

PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - AUCtau (Area Under the Curve at Steady State) [ Time Frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) ]

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3. Primary:

PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - Tmax (Time at Maximum Concentration) [ Time Frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) ]

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4. Primary:

Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality) [ Time Frame: 48 weeks ]

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5. Primary:

Treatment Discontinuation Secondary to Serious Adverse Event (SAE) Related to Study Drug [ Time Frame: Week 48 ]

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6. Secondary:

Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 (MSDF) [ Time Frame: Week 24 and Week 48 post-treatment. ]

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7. Secondary:

Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 (MSDF) [ Time Frame: Week 24 and Week 48 post-treatment ]

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8. Secondary:

Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach [ Time Frame: Week 24 and Week 48 post-treatment ]

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9. Secondary:

Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach [ Time Frame: Week 24 and Week 48 post-treatment ]

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10. Secondary:

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 [ Time Frame: Week 48 ]

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11. Secondary:

Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 post-treatment ]

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12. Secondary:

Summary of Change From Baseline in HIV-1 RNA (Original) by Visit [ Time Frame: Week 24 and Week 48 post-treatment ]

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13. Secondary:

Summary of Change From Baseline in HIV-1 RNA (Log10 Copies/mL) by Visit [ Time Frame: Week 24 and Week 48 post-treatment ]

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14. Secondary:

Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 [ Time Frame: Week 24 and Week 48 post-treatment ]

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15. Secondary:

Change From Baseline in CD4+ Percent (%) at Weeks 24 and 48 [ Time Frame: Week 24 and Week 48 post-treatment ]

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16. Secondary:

Protocol Defined Virologic Failure [ Time Frame: Week 48 ]

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17. Secondary:

Shift Table of Viral Tropism Between Screening and Confirmed PDVF Prior to Week 48 [ Time Frame: Screening and Week 48 ]

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18. Secondary:

Summary of the Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48 [ Time Frame: 48 weeks ]

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19. Secondary:

Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome [ Time Frame: 48 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although the Participant Flow Table title indicates "Overall Study", the data presented in that table is Subject Discontinuations Through Week 48. The study is ongoing.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT00791700 History of Changes
Other Study ID Numbers:	A4001031 2008-006873-33 ( EudraCT Number )
Study First Received:	November 12, 2008
Results First Received:	October 6, 2015
Last Updated:	December 21, 2016

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