Rosiglitazone Effect on Mitochondria and Lipoatrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367744
Recruitment Status : Completed
First Posted : August 23, 2006
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Rosiglitazone
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
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
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 
Lost to Follow-up                4                5 

  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
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 
[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% 
[Units: Years]
Mean (Standard Deviation)
 48  (7)   50  (7)   49.04  (7) 
[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)
 (437 to 706) 
 (423 to 861) 
 (430 to 787) 

  Outcome Measures

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

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

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

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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00367744     History of Changes
Other Study ID Numbers: AI060484-02-C
AI060484-C ( Other Grant/Funding Number: NIAID )
First Submitted: August 21, 2006
First Posted: August 23, 2006
Results First Submitted: October 5, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017