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Clinical Trial of CNS-targeted HAART (CIT2)

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ClinicalTrials.gov Identifier: NCT00624195
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ronald J Ellis, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: FDA Approved Antiretroviral Therapy (see list below)
Enrollment 59

Recruitment Details  
Pre-assignment Details  
Arm/Group Title CNS-targeted Non-CNS-targeted
Hide Arm/Group Description

CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).

Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir

Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.

Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir

Period Title: Overall Study
Started 29 30
Completed 26 23
Not Completed 3 7
Arm/Group Title CNS-targeted Non-CNS-targeted Total
Hide Arm/Group Description CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing). Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration. Total of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
30
 100.0%
59
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 59 participants
45.5  (8.8) 43.6  (11.1) 44.5  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
5
  17.2%
6
  20.0%
11
  18.6%
Male
24
  82.8%
24
  80.0%
48
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 30 participants 59 participants
29 30 59
1.Primary Outcome
Title Neuropsychological Performance Change
Hide Description The outcome measure is change in performance from baseline to 16 weeks as measured by the global deficit score (GDS). The GDS is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, gender-, and ethnicity-adjusted raw scores by methods that capture unexpectedly poor performance while ignoring better than expected performance. The GDS ranges in value from 0-5; higher scores indicate poorer cognitive functioning. Subjects with scores greater than or equal to 0.5 are considered cognitively impaired.
Time Frame Baseline and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CNS-targeted Non-CNS-targeted
Hide Arm/Group Description:
CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.27  (0.52) -0.17  (0.41)
Time Frame Entry to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CNS-targeted Non-CNS-targeted
Hide Arm/Group Description CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing). Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
All-Cause Mortality
CNS-targeted Non-CNS-targeted
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CNS-targeted Non-CNS-targeted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/30 (3.33%)    
Infections and infestations     
Death * 1  0/29 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Psychiatric Event * 1  1/29 (3.45%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, DAIDS AE system
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CNS-targeted Non-CNS-targeted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      1/30 (3.33%)    
Skin and subcutaneous tissue disorders     
Rash * 1  0/29 (0.00%)  0 1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, DAIDS AE system
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: Dr. Ron Ellis
Organization: UCSD
Phone: 619-543-5079
Responsible Party: Ronald J Ellis, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00624195     History of Changes
Other Study ID Numbers: 060154
R01MH058076-09A2 ( U.S. NIH Grant/Contract )
First Submitted: February 15, 2008
First Posted: February 27, 2008
Results First Submitted: December 9, 2013
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014