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Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease

This study has been terminated.
(Study stopped 12/2010 due to poor enrollment. Only 15 of 60 needed enrolled.)
Sponsor:
Collaborators:
University of Chicago
University of Illinois at Chicago
Ruth M. Rothstein CORE Center
Abbott
Gilead Sciences
Information provided by (Responsible Party):
Allan Tenorio, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00775606
First received: October 17, 2008
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: June 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acquired Immune Deficiency Syndrome
Interventions: Drug: Lopinavir 400 mg/ritonavir 100 mg
Drug: Efavirenz

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two subjects withdrew participation prior to starting study

Reporting Groups
  Description
ARM A/Lopinavir-ritonavir Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
ARM B/Efavirenz Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD

Participant Flow:   Overall Study
    ARM A/Lopinavir-ritonavir     ARM B/Efavirenz  
STARTED     8     5  
COMPLETED     5     5  
NOT COMPLETED     3     0  
Study sponsor terminated funding                 3                 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
ARM A Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
ARM B Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Total Total of all reporting groups

Baseline Measures
    ARM A     ARM B     Total  
Number of Participants  
[units: participants]
  8     5     13  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     5     13  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.5  ± 9.4     30.6  ± 7.1     33  ± 8.5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     5     13  
Region of Enrollment  
[units: participants]
     
United States     8     5     13  



  Outcome Measures
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1.  Primary:   CD4+ (Cluster of Differentiation 4) T-cell Apoptosis   [ Time Frame: 24 weeks from treatment initiation (baseline and week 24) ]

2.  Secondary:   CD4+ T-cell Change   [ Time Frame: 24 weeks after treatment initiation (baseline and week 24) ]

3.  Secondary:   Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines   [ Time Frame: 4 weeks after treatment initiation ]

4.  Secondary:   Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency   [ Time Frame: 4, 12 and 24 weeks after treatment initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Activated and Regulatory CD4+ and CD8+ T-cell Frequencies   [ Time Frame: 4, 12 and 24 weeks after treatment initiation ]
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
Study was terminated due to the slow recruitment and the small number of subjects.


  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: Allan R. Tenorio
Organization: Rush University Medical Center
phone: 312-942-3665
e-mail: allan_s_tenorio@rush.edu


No publications provided


Responsible Party: Allan Tenorio, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00775606     History of Changes
Other Study ID Numbers: ICE-001
Study First Received: October 17, 2008
Results First Received: June 28, 2013
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board