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Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00987948
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
University of Hawaii

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Maraviroc maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines

Participant Flow:   Overall Study

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[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

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

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

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
First Submitted: September 29, 2009
First Posted: October 1, 2009
Results First Submitted: January 20, 2015
Results First Posted: March 22, 2017
Last Update Posted: March 22, 2017