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

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ClinicalTrials.gov Identifier: NCT00308620
Recruitment Status : Terminated (Insufficient financial support; lack of efficacy for primary endpoint)
First Posted : March 29, 2006
Results First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: chloroquine phosphate
Drug: Placebo

  Participant Flow

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

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
  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 
Overall Participants Analyzed 
[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

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

Measure Type Primary
Measure Title HIV Viral Load Change
Measure Description HIV-1 viral load change between baseline and 8 weeks
Time Frame baseline and 8 weeks  

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
  Description
Chloroquine 250mg or 500mg Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
Placebo Placebo orally once daily for 8 weeks

Measured Values
   Chloroquine 250mg or 500mg   Placebo 
Participants Analyzed 
[Units: Participants]
 9   4 
HIV Viral Load Change 
[Units: Log10 copies/mL]
Log Mean (Standard Deviation)
 -.083  (.5)   0.0  (.1) 

No statistical analysis provided for HIV Viral Load Change



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

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  

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 
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


  Other Adverse Events


  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.


  More Information