Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00766597
First received: October 3, 2008
Last updated: December 28, 2015
Last verified: December 2015
Results First Received: November 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Vicriviroc

  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
Nine participants were recruited in 9 US sites between Sept 21, 2009 to June 16, 2010 prior to the early study closure on August 10, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Step I, 9 participants under Cohort I were screened for evaluation for co-receptor tropism. Five participants did not have the required tropism and were discontinued from the study. Only 4 participants had the CCR-5-tropic virus tropism, and thus were eligible to go to Step II and were assigned to receive the study drug.

Reporting Groups
  Description
Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)

HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus

Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen


Participant Flow:   Overall Study
    Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)  
STARTED     9 [1]
With CCR5-tropic Virus     4 [2]
Without CCR5-tropic Virus     5 [3]
Completed Week 24     1 [4]
Completed Week 48     0 [5]
COMPLETED     0 [6]
NOT COMPLETED     9  
Unexpected closure of study                 4  
Without CCR5-tropic virus                 5  
[1] Screened participants who were evaluated for co-receptor tropism
[2] Evaluable participants, received the study drug
[3] Not evaluable participants, did not receive the study drug
[4] Week 24 is the first primary time point of analysis
[5] Week 48 is the second primary time point of analysis
[6] Treatment duration is 48 weeks plus 5 years of follow-up



  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 HIV-1 infected antiretroviral therapy experienced participants With CCR5-tropic virus who started treatment in Step II

Reporting Groups
  Description
Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)

HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus

Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen


Baseline Measures
    Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Mean (Standard Deviation)
  15  (2.2)  
Gender  
[units: participants]
 
Female     2  
Male     2  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     2  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     1  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination   [ Time Frame: From study entry to Week 24 or the early study termination whichever occurred earlier ]

2.  Primary:   Number of Participants With Adverse Events of Grade 3 or Higher Severity   [ Time Frame: From study entry to Week 24 or the early study termination whichever occurred earlier ]

3.  Primary:   Number of Participants Who Failed to Meet PK Targets   [ Time Frame: At Week 24 ]

4.  Secondary:   Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)   [ Time Frame: At Baseline, Week 24 ]

5.  Secondary:   Number of Participants With Changes in Co-receptor Tropism From Baseline   [ Time Frame: At Baseline, Week 24 ]

6.  Secondary:   Change in CD4 Counts   [ Time Frame: At Baseline, Week 24 ]

7.  Secondary:   Change in CD4 Percent   [ Time Frame: At Baseline, Week 24 ]

8.  Secondary:   Change in Polymerase Genome and Envelope Sequence   [ Time Frame: At Baseline, Week 24 ]

9.  Secondary:   Change in Plasma HIV RNA PCR   [ Time Frame: At Baseline, Week 24 ]


  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
Study was terminated early with Merck's announcement on July 15, 2010 on the discontinuation of the development of Vicriviroc, with 4 participants given study drug and only 1 participant reached Week 24.


  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: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00766597     History of Changes
Other Study ID Numbers: P1071
10634 ( Registry Identifier: DAIDS ES )
IMPAACT P1071
Study First Received: October 3, 2008
Results First Received: November 12, 2015
Last Updated: December 28, 2015
Health Authority: United States: Food and Drug Administration