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Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00844519
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : June 19, 2014
Last Update Posted : July 24, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infection
Cardiovascular Disease
Inflammation
HIV Infections
Interventions Drug: Maraviroc
Drug: placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc Placebo
Hide Arm/Group Description maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily. matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Period Title: Overall Study
Started 26 26
Completed 24 25
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             1             0
Arm/Group Title Maraviroc Placebo Total
Hide Arm/Group Description maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily. matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
per protocol
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
52
(45 to 60)
52
(47 to 57)
52
(45 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
1
   3.8%
0
   0.0%
1
   1.9%
Male
25
  96.2%
26
 100.0%
51
  98.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 26 participants 52 participants
26 26 52
1.Primary Outcome
Title Percent Change in FMD
Hide Description endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc Placebo
Hide Arm/Group Description:
maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: percent change in FMD
0.57  (2.1) -0.05  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc
Comments within-arm, pre-post change in FMD
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments within-arm, pre-post change in FMD
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc Placebo
Hide Arm/Group Description maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily. matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
All-Cause Mortality
Maraviroc Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      0/26 (0.00%)    
Surgical and medical procedures     
hepatocellular carcinoma * [1]  1/26 (3.85%)  1 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Small mass found at ultrasound, later determined to be hepatocellular carcinoma. It is unlikely that this mass is a result of the study medication, as the patient had only been on the medication for 14 days when mass was found at ultrasound.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Priscilla Hsue
Organization: University of California San Francisco
Phone: 415-206-8257
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844519     History of Changes
Other Study ID Numbers: HIVCADRFA
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: May 19, 2014
Results First Posted: June 19, 2014
Last Update Posted: July 24, 2014