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)
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: March 27, 2006
Last updated: July 9, 2012
Last verified: May 2012
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

  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
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  
[units: participants]
<=18 years     0     0     0     0  
Between 18 and 65 years     3     4     6     13  
>=65 years     0     0     0     0  
[units: years]
Mean ± Standard Deviation
  40  ± 15     34  ± 5     36  ± 5     36.5  ± 8.0  
[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
  Show All Outcome Measures

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

2.  Secondary:   Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks   [ Time Frame: 8 weeks ]

  Serious Adverse Events

  Other Adverse Events

  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

Publications of Results:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute 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