Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV (DPPIVinHIV)

This study has been completed.
Sponsor:
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Kevin Yarasheski, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01093651
First received: March 23, 2010
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Conditions: Diabetes
Insulin Resistance
Interventions: Drug: Sitagliptin
Drug: Placebo

  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
HIV-infected adults (18 – 65 years old) were recruited from the AIDS Clinical Trials Unit and the Infectious Diseases Clinic at Washington University School of Medicine. Thirty-one candidates were screened and 20 were enrolled; all participants were HIV positive but were otherwise healthy with stable immunologic and virologic status on HAART.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty participants were randomized to n=10 placebo or n=10 sitagliptin (Januvia(R)). Eleven volunteers were screened and found ineligible (see eligibility criteria), or did not choose to participate in the study.

Reporting Groups
  Description
Placebo

Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.

Placebo : Daily placebo for 4 months

DPPIV Inhibition

Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.

Sitagliptin : 100 mg sitagliptin daily for 4 months


Participant Flow:   Overall Study
    Placebo     DPPIV Inhibition  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Placebo

Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.

Placebo : Daily placebo for 4 months

DPPIV Inhibition

Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.

Sitagliptin : 100 mg sitagliptin daily for 4 months

Total Total of all reporting groups

Baseline Measures
    Placebo     DPPIV Inhibition     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 15     36  ± 9     38  ± 12  
Gender  
[units: participants]
     
Female     2     1     3  
Male     8     9     17  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   CD4+ T-cell Count   [ Time Frame: Monthly for 4 months ]

2.  Primary:   Plasma HIV Viremia (Viral Load)   [ Time Frame: Monthly for 6 months ]

3.  Secondary:   Soluble TNFR2; Serum Biomarkers of Immune Activation   [ Time Frame: Baseline, week 8, week 16 ]

4.  Secondary:   SDF1α; Serum Biomarkers of Immune Activation   [ Time Frame: Baseline, week 8, week 16 ]

5.  Secondary:   RANTES; Serum Biomarkers of Immune Activation   [ Time Frame: Baseline, week 8, week 16 ]

6.  Secondary:   Oral Glucose Tolerance   [ Time Frame: Baseline, week 8, week 16 ]

7.  Secondary:   Self-reported Symptoms   [ Time Frame: Monthly for 4 months ]


  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
Potential for type 2 error given small sample size. But, study was powered to detect significant decline in CD4 count. Measures of monocyte and lymphocyte activation should be conducted.


  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: Kevin Yarasheski, PhD
Organization: Washington Univ Med Sch
phone: 3143628173
e-mail: key@wustl.edu


Publications of Results:

Responsible Party: Kevin Yarasheski, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01093651     History of Changes
Other Study ID Numbers: KEY03222010
Study First Received: March 23, 2010
Results First Received: May 13, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board