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A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease

This study has been completed.
Sponsor:
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01578772
First received: February 1, 2012
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Endothelial Dysfunction
Intervention: Drug: Telmisartan

  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
No text entered.

Reporting Groups
  Description
Telmisartan

Open label

Telmisartan: 80mg tablets po daily for 6 weeks


Participant Flow:   Overall Study
    Telmisartan  
STARTED     17  
COMPLETED     17  
NOT COMPLETED     0  



  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.
HIV-infected individual >50 years old with HIV-1 RNA <50 copies /mL on stable ART and >=1 CVD risk factor.

Reporting Groups
  Description
Telmisartan

Open label

Telmisartan: 80mg tablets po daily for 6 weeks


Baseline Measures
    Telmisartan  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Median ( Inter-Quartile Range )
  60  
  ( 54 to 63 )  
Gender  
[units: participants]
 
Female     2  
Male     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy   [ Time Frame: 6 weeks (after baseline) ]

2.  Primary:   6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy   [ Time Frame: 6 weeks (after baseline) ]


  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
Given the limited size of the study population, the study was underpowered.


  More Information
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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. Jordan Lake
Organization: UCLA
phone: 310-557-2273
e-mail: jlake@mednet.ucla.edu


No publications provided


Responsible Party: Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01578772     History of Changes
Other Study ID Numbers: miFMD
Study First Received: February 1, 2012
Results First Received: September 4, 2014
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board