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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:
Information provided by (Responsible Party):

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


  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.
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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 
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 ]

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


  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
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  More Information