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Metabolic Abnormalities in HIV-infected Persons

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01612858
First received: June 4, 2012
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lipodystrophy
HIV Infection
Interventions: Drug: Metformin
Drug: Pioglitazone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
Pioglitazone Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.

Participant Flow:   Overall Study
    Metformin     Pioglitazone  
STARTED     16     4  
COMPLETED     11     3  
NOT COMPLETED     5     1  
Withdrawal by Subject                 5                 1  



  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
Metformin Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
Pioglitazone Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Total Total of all reporting groups

Baseline Measures
    Metformin     Pioglitazone     Total  
Number of Participants  
[units: participants]
  16     4     20  
Age  
[units: years]
Mean (Standard Deviation)
  53.9  (7.9)     55.7  (8.6)     54.2  (7.8)  
Gender  
[units: participants]
     
Female     4     0     4  
Male     12     4     16  



  Outcome Measures
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1.  Primary:   Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent   [ Time Frame: 3 months ]

2.  Secondary:   Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent   [ 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:  
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: Rakhi Kohli MD MS
Organization: Tufts Medical Center
phone: 617-636-4709
e-mail: rkohli@tuftsmedicalcenter.org



Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01612858     History of Changes
Other Study ID Numbers: CLAMP-K23
1K23DK079789-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: June 4, 2012
Results First Received: May 12, 2016
Last Updated: May 12, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board