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

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ClinicalTrials.gov Identifier: NCT00775606
Recruitment Status : Terminated (Study stopped 12/2010 due to poor enrollment. Only 15 of 60 needed enrolled.)
First Posted : October 20, 2008
Results First Posted : May 29, 2014
Last Update Posted : June 9, 2014
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acquired Immune Deficiency Syndrome
Interventions Drug: Lopinavir 400 mg/ritonavir 100 mg
Drug: Efavirenz
Enrollment 15
Recruitment Details  
Pre-assignment Details Two subjects withdrew participation prior to starting study
Arm/Group Title ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Hide Arm/Group Description Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Period Title: Overall Study
Started 8 5
Completed 5 5
Not Completed 3 0
Reason Not Completed
Study sponsor terminated funding             3             0
Arm/Group Title ARM A ARM B Total
Hide Arm/Group Description Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD Total of all reporting groups
Overall Number of Baseline Participants 8 5 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 5 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
5
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 5 participants 13 participants
34.5  (9.4) 30.6  (7.1) 33  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 5 participants 13 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
5
 100.0%
13
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 5 participants 13 participants
8 5 13
1.Primary Outcome
Title CD4+ (Cluster of Differentiation 4) T-cell Apoptosis
Hide Description Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.
Time Frame 24 weeks from treatment initiation (baseline and week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Hide Arm/Group Description:
Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: per cent
-12.33  (12.34) -8.01  (7.97)
2.Secondary Outcome
Title CD4+ T-cell Change
Hide Description This measures the change in CD4+ T-cells from baseline to week 24 of treatment.
Time Frame 24 weeks after treatment initiation (baseline and week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Hide Arm/Group Description:
Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: cells/mm3
176.83  (101.39) 102.6  (150.45)
3.Secondary Outcome
Title Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency
Hide Description [Not Specified]
Time Frame 4, 12 and 24 weeks after treatment initiation
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Activated and Regulatory CD4+ and CD8+ T-cell Frequencies
Hide Description [Not Specified]
Time Frame 4, 12 and 24 weeks after treatment initiation
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines
Hide Description Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size
Time Frame 4 weeks after treatment initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARM A ARM B
Hide Arm/Group Description:
Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Hide Arm/Group Description Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
All-Cause Mortality
ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ARM A/Lopinavir-ritonavir ARM B/Efavirenz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      0/5 (0.00%)    
Hepatobiliary disorders     
Grade 3 elevation in ALT  [1]  1/8 (12.50%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Not related to study treatment. Related to alcohol use.
Study was terminated due to the slow recruitment and the small number of subjects.
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
Responsible Party: Allan Tenorio, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00775606     History of Changes
Other Study ID Numbers: ICE-001
First Submitted: October 17, 2008
First Posted: October 20, 2008
Results First Submitted: June 28, 2013
Results First Posted: May 29, 2014
Last Update Posted: June 9, 2014