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Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine

This study has been terminated.
(Insufficient financial support; lack of efficacy for primary endpoint)
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00308620
First received: March 27, 2006
Last updated: July 9, 2012
Last verified: May 2012
History of Changes
Results First Received: September 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: chloroquine phosphate
Drug: Placebo

  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
2006-2008 recruitment of volunteers in HIV care but electing to not receive ART.

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
Chloroquine 500mg Chloroquine 500mg PO once daily x 8 weeks
Placebo Placebo once daily for 8 weeks
Chloroquine 250mg Chloroquine 250mg PO once daily x 8 weeks

Participant Flow:   Overall Study
    Chloroquine 500mg     Placebo     Chloroquine 250mg  
STARTED     3     4     6  
COMPLETED     2     3     5  
NOT COMPLETED     1     1     1  
Death                 1                 1                 0  
Lost to Follow-up                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Chloroquine 500mg Chloroquine 500mg PO once daily x 8 weeks
Placebo Placebo once daily for 8 weeks
Chloroquine 250mg Chloroquine 250mg PO once daily x 8 weeks
Total Total of all reporting groups

Baseline Measures
    Chloroquine 500mg     Placebo     Chloroquine 250mg     Total  
Number of Participants  
[units: participants]
 		  3     4     6     13  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     4     6     13  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  40  ± 15     34  ± 5     36  ± 5     36.5  ± 8.0  
Gender  
[units: participants]
 		       
Female     0     1     0     1  
Male     3     3     6     12  
Region of Enrollment  
[units: participants]
 		       
United States     3     4     6     13  



  Outcome Measures
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1.  Primary:   HIV Viral Load Change   [ Time Frame: baseline and 8 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks   [ Time Frame: 8 weeks ]
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Measure Type Secondary
Measure Title Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
Measure Description The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.
Time Frame 8 weeks  
Safety Issue No  

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.
Analysis of Chloroquine arms is pooled.

Reporting Groups
  Description
Chloroquine 250mg or 500mg Chloroquine 500mg orally once daily x 8 weeks
Placebo Placebo orally once daily for 8 weeks

Measured Values
    Chloroquine 250mg or 500mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  7     3  
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks  
[units: percentage change]
Median ( Full Range ) 		   
CD8 CD38+HLA-DR+     -2.5  
  ( -7 to 2 )   		  1.85  
  ( -3 to 2 )  
CD4 ki67+     -2.0  
  ( -3 to 2 )   		  1.4  
  ( -0.5 to 3 )  

No statistical analysis provided for Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks




  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: David Boulware
Organization: University of Minnesota
phone: 6126269546
e-mail: boulw001@umn.edu


Publications of Results:


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00308620     History of Changes
Other Study ID Numbers: 0510M77007
Study First Received: March 27, 2006
Results First Received: September 26, 2011
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board