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A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01327547
First received: March 22, 2011
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: April 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Coinfection
Interventions: Drug: Maraviroc
Drug: Placebo

  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
In this 148 week, multicenter, multi-national, double-blind, randomized, placebo-controlled Phase 4 study, a total of 138 participants were randomized, out of which 137 participants received the study drug. The study was conducted in 43 centers in 9 countries. This document presents all data analyzed through Week 48 of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.

Reporting Groups
  Description
Maraviroc Participants who received maraviroc in combination with HAART
Placebo Participants who received placebo in combination with HAART

Participant Flow:   Overall Study
    Maraviroc     Placebo  
STARTED     70     67  
In Study, Off Drug     2     2  
COMPLETED     0     0  
NOT COMPLETED     70     67  
Adverse Event                 4                 1  
Death                 0                 1  
Lost to Follow-up                 3                 1  
Non-Compliance With Study Treatment                 0                 1  
Withdrawal by Subject                 2                 4  
Does Not Meet Entrance Criteria                 2                 2  
Non-compliance - alcohol consumption                 0                 1  
Requirement for prohibited medication                 2                 0  
Non-compliance with study procedures                 1                 0  
Continuing in the study                 56                 56  



  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.
No text entered.

Reporting Groups
  Description
Maraviroc Participants who received maraviroc in combination with HAART
Placebo Participants who received placebo in combination with HAART
Total Total of all reporting groups

Baseline Measures
    Maraviroc     Placebo     Total  
Number of Participants  
[units: participants]
  70     67     137  
Age, Customized  
[units: Participants]
     
<18 years     0     0     0  
18-44 years     26     20     46  
45-64 years     42     47     89  
≥65 years     2     0     2  
Gender  
[units: Participants]
     
Female     10     10     20  
Male     60     57     117  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48   [ Time Frame: 48 weeks ]

2.  Secondary:   Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48   [ Time Frame: 48 weeks ]

3.  Secondary:   Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L at Week 48   [ Time Frame: 48 weeks ]

4.  Secondary:   Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48 Associated With a Change From Baseline ALT >100 IU/L   [ Time Frame: 48 weeks ]

5.  Secondary:   Percentage of Participants With Hy's Law Abnormalities at Week 48   [ Time Frame: 48 weeks ]

6.  Secondary:   Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

7.  Secondary:   Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48   [ Time Frame: 48 weeks ]

8.  Secondary:   Change From Baseline in Markers of Immune Activation: CD38 Expression on CD4 and CD8 Cells - Week 48   [ Time Frame: 48 weeks ]

9.  Secondary:   Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48   [ Time Frame: 48 weeks ]

10.  Secondary:   Change From Baseline in Markers of Immune Activation: D Dimer - Week 48   [ Time Frame: 48 weeks ]

11.  Secondary:   Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48   [ Time Frame: 48 weeks ]

12.  Secondary:   Change From Baseline in Plasma Hepatitis C Virus (HCV) RNA at Week 48   [ Time Frame: 48 weeks ]

13.  Secondary:   Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48   [ Time Frame: 48 weeks ]

14.  Secondary:   Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48   [ Time Frame: 48 weeks ]

15.  Secondary:   Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
Results of the population pharmacokinetic analysis and exposure-response relationship between maraviroc pharmacokinetics and liver fibrosis biomarkers at 48 weeks, will be included when the Basic Results are finalized off the Last Subject Last Visit.


  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:
unchecked 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.
unchecked 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.


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


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01327547     History of Changes
Other Study ID Numbers: A4001098, 2010-021994-35
Study First Received: March 22, 2011
Results First Received: April 9, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration