Sitagliptin and HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Yarasheski, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01552694
First received: March 8, 2012
Last updated: March 4, 2015
Last verified: March 2015
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Inflammation
Macrophage Infiltration
Cardiovascular Disease
Interventions: Drug: Sitagliptin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
38 participants were initially enrolled. 1 was lost to follow-up; 1 started a personal exercise training program while enrolled in the study. Any data collected on these 2 participants were excluded from the analysis. Both were initially enrolled in the placebo group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
36 participants completed the trial with complete data.

Reporting Groups
  Description
Sitagliptin

100 mg sitagliptin/day for 2 months

Sitagliptin: Oral, 100 mg/day for 2 months

Placebo

Matching placebo daily for 2 months

Placebo: oral, matching placebo daily for 2 months


Participant Flow:   Overall Study
    Sitagliptin     Placebo  
STARTED     18     20  
COMPLETED     18     18  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 1  
Protocol Violation                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Sitagliptin

100 mg sitagliptin/day for 2 months

Sitagliptin: Oral, 100 mg/day for 2 months

Placebo

Matching placebo daily for 2 months

Placebo: oral, matching placebo daily for 2 months

Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Placebo     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: years]
Mean ± Standard Deviation
  49  ± 9     52  ± 6     51  ± 7  
Gender  
[units: participants]
     
Female     5     5     10  
Male     13     13     26  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     2     11     13  
African American     16     7     23  
Region of Enrollment  
[units: participants]
     
United States     18     18     36  
Weight  
[units: kg]
Mean ± Standard Deviation
  97  ± 21     102  ± 29     100  ± 25  
Body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
  32.7  ± 8.2     33.1  ± 8.2     32.9  ± 8.2  
Waist circumference  
[units: cm]
Mean ± Standard Deviation
  106  ± 19     112  ± 23     109  ± 22  
Systolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  124  ± 15     127  ± 14     125  ± 14  
Diastolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  74  ± 9     78  ± 10     76  ± 10  
HIV duration  
[units: years]
Mean ± Standard Deviation
  14.9  ± 5.8     14.2  ± 7.5     14.6  ± 6.2  
CD4+ T-cell count  
[units: cells/µL]
Mean ± Standard Deviation
  731  ± 220     606  ± 218     668  ± 219  
CD8+ T-cell count  
[units: cells/µL]
Mean ± Standard Deviation
  1017  ± 542     801  ± 294     909  ± 418  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Inflammatory Biomarker 1: Plasma hsCRP Concentration   [ Time Frame: 2 months ]

2.  Primary:   Inflammatory Biomarker 2: Plasma IL-6 Concentration   [ Time Frame: 2 months ]

3.  Primary:   Inflammatory Biomarker 3: Serum D-dimer Concentration   [ Time Frame: 2 months ]

4.  Secondary:   Adipose Inflammation   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Blood Endothelial Progenitor Cells   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Kevin Yarasheski, PhD
Organization: Washington University School of Medicine
phone: 3143628173
e-mail: key@wustl.edu


No publications provided


Responsible Party: Kevin Yarasheski, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552694     History of Changes
Other Study ID Numbers: 41052, 41052
Study First Received: March 8, 2012
Results First Received: February 5, 2015
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board