Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
|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: NCT00844519|
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : June 19, 2014
Last Update Posted : July 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Cardiovascular Disease Inflammation HIV Infections||Drug: Maraviroc Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||June 2014|
Active Comparator: Maraviroc
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
|Placebo Comparator: Placebo||
For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
- Percent Change in FMD [ Time Frame: Baseline, 24 weeks ]endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844519
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94110|