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A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
David Pitrak, University of Chicago
ClinicalTrials.gov Identifier:
NCT00145795
First received: September 1, 2005
Last updated: August 23, 2013
Last verified: August 2013
Results First Received: October 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Kaletra + Current Dual NRTI Backbone
Drug: Current Regimen

  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
Patients were enrolled from the outpatient clinics at the University of Chicago and the University of Illinois, with approval from the Institutional Review Board at each institution.

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 + Current Dual NRTI Backbone Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
Current Regimen Patients in this study arm continued their current regimen.

Participant Flow:   Overall Study
    Kaletra + Current Dual NRTI Backbone     Current Regimen  
STARTED     10     10  
COMPLETED     9 [1]   10  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  
[1] 1 patient discontinued early due to grade II gastrointestinal symptoms.



  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 + Current Dual NRTI Backbone Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
Current Regimen Patients in this study arm continued their current regimen.
Total Total of all reporting groups

Baseline Measures
    Kaletra + Current Dual NRTI Backbone     Current Regimen     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 14.4     40.5  ± 9.6     43  ± 11.9  
Gender  
[units: participants]
     
Female     2     1     3  
Male     8     9     17  
CD4 T cell count/mm^3  
[units: number of cells per cubic mm]
Mean ± Standard Deviation
  172  ± 89     264  ± 106     218  ± 95.3  
Immune response at enrollment [1]
[units: participants]
     
Nonresponder     5     5     10  
Partial responder     5     5     10  
Complete responder     0     0     0  
Duration of HAART prior to study entry  
[units: months]
Mean ± Standard Deviation
  28.8  ± 23.4     38.3  ± 28.8     33.6  ± 25.5  
HAART regimen at enrollment [2]
[units: participants]
     
Two NRTIs + NNRTI     7     6     13  
Two NRTIs + PI     2     1     3  
Two NRTIs + boosted PI     0     1     1  
Three NRTIs     1     2     3  
[1]

We grouped patients according to their baseline absolute CD4+ lymphocyte counts before the initiation of HAART as follows: group 1, CD4+ <100/mm3; group 2, 100–199/mm3; group 3, 200–399/mm3, group 4, 400–699/mm3; and group 5, >= 700/mm3.

Then, we categorized patients as complete or partial immune responders as follows. Complete immune responders have CD4+ counts increase to >700/mm3 after initiation of HAART. Partial immune responders have an increase in CD4+ count of >50% and improvement by at least one immunological grouping. All other patients are considered nonresponders.

[2] NRTI: nucleoside reverse transcriptase inhibitor; NNRTI: non-nucleoside reverse transcriptase inhibitor; PI: protease inhibitor; Boosted PI: Combine low-dose ritonavir with a second PI and two or more NRTIs



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Immune Reconstitution [3 Months]   [ Time Frame: 3 months ]

2.  Primary:   Immune Reconstitution [6 Months]   [ Time Frame: 6 months ]

3.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months]   [ Time Frame: 3 months ]

4.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months]   [ Time Frame: 3 months ]

5.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months]   [ Time Frame: 6 months ]

6.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months]   [ Time Frame: 6 months ]

7.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months]   [ Time Frame: 3 months ]

8.  Secondary:   Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months]   [ Time Frame: 6 months ]

9.  Secondary:   Clinical HIV-related Events   [ Time Frame: 6 months ]

10.  Secondary:   Rates of Virologic Failure   [ Time Frame: 6 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
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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: Dr. David Pitrak
Organization: The University of Chicago Department of Health Studies, Section of Infectious Diseases and Global Health
phone: (773) 702-2710
e-mail: dpitrak@medicine.bsd.uchicago.edu


Publications of Results:

Responsible Party: David Pitrak, University of Chicago
ClinicalTrials.gov Identifier: NCT00145795     History of Changes
Other Study ID Numbers: 11711B
Study First Received: September 1, 2005
Results First Received: October 24, 2012
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board