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Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00987948
First received: September 29, 2009
Last updated: February 1, 2017
Last verified: February 2017
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: maraviroc (Selzentry)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Maraviroc maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines

Participant Flow:   Overall Study
    Maraviroc
STARTED   15 
COMPLETED   12 
NOT COMPLETED   3 



  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.
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Reporting Groups
  Description
Maraviroc maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines

Baseline Measures
   Maraviroc 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  93.3% 
>=65 years      1   6.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1   6.7% 
Male      14  93.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   6.7% 
Native Hawaiian or Other Pacific Islander      1   6.7% 
Black or African American      0   0.0% 
White      11  73.3% 
More than one race      2  13.3% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
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1.  Primary:   Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells   [ Time Frame: Baseline to 24 weeks ]

2.  Secondary:   Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores   [ Time Frame: Baseline to 24 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cecilia M Shikuma
Organization: Hawaii Center for AIDS, University of Hawaii
phone: 8086921328
e-mail: shikuma@hawaii.edu



Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT00987948     History of Changes
Other Study ID Numbers: H005
Study First Received: September 29, 2009
Results First Received: January 20, 2015
Last Updated: February 1, 2017