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HIV and Fat Accumulation (MATH)

This study has been completed.
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01088295
First received: March 16, 2010
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
Results First Received: January 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
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
Subjects were recruited between May and October 2010 at the UCLA CARE Center.

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 Telmisartan 40mg po daily for 24 weeks

Participant Flow:   Overall Study
    Telmisartan  
STARTED     36  
COMPLETED     35  
NOT COMPLETED     1  



  Baseline Characteristics
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Reporting Groups
  Description
Telmisartan Telmisartan 40mg po daily for 24 weeks

Baseline Measures
    Telmisartan  
Number of Participants  
[units: participants]
 		  36  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  49  ± 7.4  
Gender  
[units: participants]
 		 
Female     16  
Male     20  
Region of Enrollment  
[units: participants]
 		 
United States     36  



  Outcome Measures

1.  Primary:   Median Change in Visceral Adipose Tissue (VAT) Volume   [ Time Frame: Baseline and 24 weeks ]
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Measure Type Primary
Measure Title Median Change in Visceral Adipose Tissue (VAT) Volume
Measure Description VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Time Frame Baseline and 24 weeks  
Safety Issue No  

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.
as-treated analysis

Reporting Groups
  Description
Telmisartan Telmisartan 40mg po daily for 24 weeks

Measured Values
    Telmisartan  
Number of Participants Analyzed  
[units: participants]
 		  35  
Median Change in Visceral Adipose Tissue (VAT) Volume  
[units: cm^2]
Median ( Inter-Quartile Range ) 		  -4.6  
  ( -29.5 to 31.2 )  

No statistical analysis provided for Median Change in Visceral Adipose Tissue (VAT) Volume



2.  Secondary:   Safety and Tolerability of Telmisartan   [ Time Frame: 24 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Jordan E. Lake, M.D., M.Sc.
Organization: University of California, Los Angeles
phone: (310)557-1891
e-mail: jlake@mednet.ucla.edu


No publications provided by University of California, Los Angeles

Publications automatically indexed to this study:


Responsible Party: Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01088295     History of Changes
Other Study ID Numbers: MATH
Study First Received: March 16, 2010
Results First Received: January 16, 2013
Last Updated: February 15, 2013
Health Authority: United States: Food and Drug Administration