Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study

This study has been terminated.
(Inability to enroll subjects.)
Sponsor:
Information provided by (Responsible Party):
Charles E. Davis, Jr. MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT00344487
First received: June 22, 2006
Last updated: December 17, 2014
Last verified: December 2014
Results First Received: August 3, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: Lopinavir/Ritonavir

  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
This study received IRb approval on 12/7/05. Recruitment was difficult and the inclusion criteria was amended in November 2007 to help increase enrollment.

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
Kaletra Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.

Participant Flow:   Overall Study
    Kaletra  
STARTED     3  
COMPLETED     2 [1]
NOT COMPLETED     1  
immunologic failure                 1  
[1] One subject was withdrawn at month 9 because he was considered an immunologic failure on study.



  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
Kaletra Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks

Baseline Measures
    Kaletra  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  43  (3)  
Gender  
[units: participants]
 
Female     0  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Changes From Baseline in CD4 Cell Percentage at 6 and 12 Months   [ Time Frame: Baseline, 6 and 12 months ]

2.  Primary:   Absolute Change in CD4 Cell Count From Baseline, and at 6 and 12 Months   [ Time Frame: 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Changes From Baseline in CD4 Cell Count at 6 and 12 Months   [ Time Frame: 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).   [ Time Frame: 3, 6, 0r 9, 12 months respectively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Primary:   Changes in the Slope of CD4 as Assessed 6 Months Prior to the Lopinavir/Ritonavir Switch (Baseline), Compared to 6-12 Month Intervals Post Initiation of Lopinavir/Ritonavir (Slope 1-6 Months, 1-12 Months)   [ Time Frame: 6 and 12 months ]
Results not yet reported.   Anticipated Reporting 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
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  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: Charles E. Davis, Jr. MD
Organization: University of Maryland Institute of Human Virology
phone: 410-706-1684
e-mail: cdavis@ihv.umaryland.edu


No publications provided


Responsible Party: Charles E. Davis, Jr. MD, University of Maryland
ClinicalTrials.gov Identifier: NCT00344487     History of Changes
Other Study ID Numbers: H-27050
Study First Received: June 22, 2006
Results First Received: August 3, 2012
Last Updated: December 17, 2014
Health Authority: United States: Institutional Review Board