Atorvastatin for HAART Suboptimal Responders

This study has been completed.
Sponsor:
Collaborator:
Vaccine and Gene Therapy Institute, Florida
Information provided by (Responsible Party):
College of Health Sciences, Makerere University
ClinicalTrials.gov Identifier:
NCT01766076
First received: December 10, 2012
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acquired Immune Deficiency Syndrome Virus
Interventions: Other: atorvastatin, Lipitor®
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
30 participants were recruited from the Infectious Diseases Institute research cohort (single site) and followed up for 12 weeks, 4 weeks wash out period and 12 weeks after cross over of treatment assignment

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were selected if they had sustained viral suppression for 7 years and CD4 increases below 300 cells/ul

Reporting Groups
  Description
Atorvastatin First, Then Placebo

Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.

PBMC were collected for immune activation assays using flowcytometry

'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry

Placebo First, Then Atorvastatin

Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry

Placebo: PBMC were collected for immune activation assays using flowcytometry


Participant Flow:   Overall Study
    Atorvastatin First, Then Placebo     Placebo First, Then Atorvastatin  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  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
  Description
Atorvastatin First, Then Placebo

Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.

PBMC will be collected for immune activation assays using flowcytometry

'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry

Placebo First, Then Atorvastatin

Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry

Placebo: PBMC were collected for immune activation assays using flowcytometry

Total Total of all reporting groups

Baseline Measures
    Atorvastatin First, Then Placebo     Placebo First, Then Atorvastatin     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Age  
[units: years]
Median (Inter-Quartile Range)
  41   (40 to 50)     47   (43 to 51)     46   (40 to 51)  
Gender  
[units: participants]
     
Female     7     10     17  
Male     8     5     13  
Region of Enrollment  
[units: participants]
     
Uganda     15     15     30  
CD4 T-cell activation  
[units: percenatage of activated CD4 T-cells]
Median (Inter-Quartile Range)
  4.2   (3.7 to 6.2)     2.9   (2.9 to 5.0)     4.2   (1.5 to 8.3)  



  Outcome Measures

1.  Primary:   Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Damalie Nakanjako
Organization: Makarere University
phone: 41407000 ext 249
e-mail: dnakanjako@gmail.com


Publications:

Responsible Party: College of Health Sciences, Makerere University
ClinicalTrials.gov Identifier: NCT01766076     History of Changes
Other Study ID Numbers: HS1258
Study First Received: December 10, 2012
Results First Received: July 17, 2014
Last Updated: May 20, 2015
Health Authority: Uganda: National Council for Science and Technology