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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: June 19, 2014
Last verified: June 2014
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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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.
No text entered.

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 ]

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Telmisartan No text entered.

Other Adverse Events
    Telmisartan  
Total, other (not including serious) adverse events    
# participants affected / at risk     0/35  



  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
No text entered.


  More Information