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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


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


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: June 19, 2014
Health Authority: United States: Food and Drug Administration