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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 : June 4, 2020
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota

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
Enrollment 13
Recruitment Details 2006-2008 recruitment of volunteers in HIV care but electing to not receive ART.
Pre-assignment Details  
Arm/Group Title Chloroquine 500mg Placebo Chloroquine 250mg
Hide Arm/Group Description Chloroquine 500mg PO once daily x 8 weeks Placebo once daily for 8 weeks Chloroquine 250mg PO once daily x 8 weeks
Period Title: Overall Study
Started 3 4 6
Completed 2 3 5
Not Completed 1 1 1
Reason Not Completed
Death             1             1             0
Lost to Follow-up             0             0             1
Arm/Group Title Chloroquine 500mg Placebo Chloroquine 250mg Total
Hide Arm/Group Description Chloroquine 500mg PO once daily x 8 weeks Placebo once daily for 8 weeks Chloroquine 250mg PO once daily x 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 3 4 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
4
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 6 participants 13 participants
40  (15) 34  (5) 36  (5) 36.5  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 6 participants 13 participants
Female
0
   0.0%
1
  25.0%
0
   0.0%
1
   7.7%
Male
3
 100.0%
3
  75.0%
6
 100.0%
12
  92.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 6 participants 13 participants
3 4 6 13
1.Primary Outcome
Title HIV Viral Load Change
Hide Description HIV-1 viral load change between baseline and 8 weeks
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chloroquine 250mg or 500mg Placebo
Hide Arm/Group Description:
Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
Placebo orally once daily for 8 weeks
Overall Number of Participants Analyzed 9 4
Log Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-.083  (.5) 0.0  (.1)
2.Secondary Outcome
Title Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Chloroquine arms is pooled.
Arm/Group Title Chloroquine 250mg or 500mg Placebo
Hide Arm/Group Description:
Chloroquine 500mg orally once daily x 8 weeks
Placebo orally once daily for 8 weeks
Overall Number of Participants Analyzed 7 3
Median (Full Range)
Unit of Measure: percentage change
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chloroquine 500mg Placebo Chloroquine 250mg
Hide Arm/Group Description Chloroquine 500mg PO once daily x 8 weeks Placebo once daily for 8 weeks Chloroquine 250mg PO once daily x 8 weeks
All-Cause Mortality
Chloroquine 500mg Placebo Chloroquine 250mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Chloroquine 500mg Placebo Chloroquine 250mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/4 (25.00%)      0/6 (0.00%)    
Social circumstances       
Death (non-related) * [1]  1/3 (33.33%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Autopsy Report
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chloroquine 500mg Placebo Chloroquine 250mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)      0/6 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: David Boulware
Organization: University of Minnesota
Phone: 6126269546
EMail: boulw001@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00308620    
Other Study ID Numbers: 0510M77007
First Submitted: March 27, 2006
First Posted: March 29, 2006
Results First Submitted: September 26, 2011
Results First Posted: August 17, 2012
Last Update Posted: June 4, 2020