Clinical Trial of CNS-targeted HAART (CIT2)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Ronald J Ellis, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00624195
First received: February 15, 2008
Last updated: March 21, 2014
Last verified: March 2014
Results First Received: December 9, 2013  
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
Intervention: Drug: FDA Approved Antiretroviral Therapy (see list below)

  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
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Reporting Groups
  Description
CNS-targeted

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

Non-CNS-targeted

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


Participant Flow:   Overall Study
    CNS-targeted     Non-CNS-targeted  
STARTED     29     30  
COMPLETED     26     23  
NOT COMPLETED     3     7  



  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.
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Reporting Groups
  Description
CNS-targeted 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).
Non-CNS-targeted 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 Total of all reporting groups

Baseline Measures
    CNS-targeted     Non-CNS-targeted     Total  
Number of Participants  
[units: participants]
  29     30     59  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     29     30     59  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 8.8     43.6  ± 11.1     44.5  ± 9.9  
Gender  
[units: participants]
     
Female     5     6     11  
Male     24     24     48  
Region of Enrollment  
[units: participants]
     
United States     29     30     59  



  Outcome Measures

1.  Primary:   Neuropsychological Performance Change   [ Time Frame: Baseline and 16 weeks ]


  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:  
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
e-mail: roellis@ucsd.edu


Publications of Results:
Other Publications:

Responsible Party: Ronald J Ellis, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00624195     History of Changes
Other Study ID Numbers: 060154, R01MH058076-09A2
Study First Received: February 15, 2008
Results First Received: December 9, 2013
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board