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Trial record 5 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

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ClinicalTrials.gov Identifier: NCT00987948
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Pfizer
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)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc
Hide Arm/Group Description maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Arm/Group Title Maraviroc
Hide Arm/Group Description maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
1
   6.7%
Male
14
  93.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title 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
Hide Description Week 24 minus baseline
Time Frame Baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure in the 12 patients who completed the study.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: Log-10 copies/10^6 cells
0.58
(0.00 to 2.20)
2.Secondary Outcome
Title Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores
Hide Description The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 of 12 patients who completed the study who had mild to moderate cognitive impairment
Arm/Group Title Maraviroc
Hide Arm/Group Description:
maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Overall Number of Participants Analyzed 6
Median (Inter-Quartile Range)
Unit of Measure: Z-score
0.57
(0.35 to 1.07)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc
Hide Arm/Group Description maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
All-Cause Mortality
Maraviroc
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Endocrine disorders   
Pancreatitis  [1]  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
Patient developed abdominal pain at 4 weeks post initiation of study; diagnosed to have pancreatitis. Study medications stopped with resolution of symptoms. SAE assessed as possibly related to maraviroc. MedWatch form filled out.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
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
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