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Rosiglitazone Effect on Mitochondria and Lipoatrophy

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00367744
First received: August 21, 2006
Last updated: December 8, 2016
Last verified: August 2006
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Rosiglitazone
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
Recruited at Case Western Reserve University and Cleveland Clinic. Recruitment occurred between from July 2006 (first subject was randomized) to December 2007 (last subject was randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 71 subjects were randomized. Results are reported for 71 subjects.

Reporting Groups
  Description
Rosiglitazone Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
Placebo Placebo arm for the whole duration of the study

Participant Flow:   Overall Study
    Rosiglitazone   Placebo
STARTED   34   37 
COMPLETED   30   32 
NOT COMPLETED   4   5 
Lost to Follow-up                4                5 



  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
Rosiglitazone Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
Placebo Placebo arm
Total Total of all reporting groups

Baseline Measures
   Rosiglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   37   71 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      37 100.0%      71 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (7)   50  (7)   49.04  (7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  14.7%      7  18.9%      12  16.9% 
Male      29  85.3%      30  81.1%      59  83.1% 
Region of Enrollment 
[Units: Participants]
     
United States   34   37   71 
CD4+ cell count 
[Units: Cells/mm3]
Median (Inter-Quartile Range)
 596 
 (437 to 706) 
 691 
 (423 to 861) 
 645.5 
 (430 to 787) 


  Outcome Measures
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1.  Primary:   Change in Limb Fat at 48 Weeks   [ Time Frame: 48 weeks ]

2.  Secondary:   the Change in the Carotid IMT of the Common Carotid Artery   [ Time Frame: 48 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
Limitations of the study include a relative small sample size as well as loss of follow up of 9 participants at the end of the study.


  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.


Results Point of Contact:  
Name/Title: Dr. Grace McComsey
Organization: Case Western Reserve University
phone: 216 844 3607
e-mail: mccomsey.grace@clevelandactu.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00367744     History of Changes
Other Study ID Numbers: AI060484-02-C
AI060484-C ( Other Grant/Funding Number: NIAID )
Study First Received: August 21, 2006
Results First Received: October 5, 2016
Last Updated: December 8, 2016