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Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marshall Jay Glesby, MD, PhD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00130286
First received: August 12, 2005
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV-Associated Lipodystrophy Syndrome
Insulin Resistance
HIV Infections
Metabolic Syndrome X
Body Weight Changes
Interventions: Drug: Rosiglitazone
Drug: Recombinant human growth hormone + rosiglitazone

  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
rhGH + Rosi

Recombinant human growth hormone + rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH Placebo + Rosi

Placebo for recombinant human growth hormone + rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH + Rosi Placebo

Recombinant human growth hormone + placebo for rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Double Placebo

Placebo for recombinant human growth hormone + placebo for rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)


Participant Flow:   Overall Study
    rhGH + Rosi     rhGH Placebo + Rosi     rhGH + Rosi Placebo     Double Placebo  
STARTED     22     19     17     19  
COMPLETED     22     16     13     17  
NOT COMPLETED     0     3     4     2  
Withdrawal by Subject                 0                 1                 2                 2  
Adverse Event                 0                 0                 2                 0  
Missing lab specimens                 0                 2                 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
rhGH + Rosi

Recombinant human growth hormone + rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH Placebo + Rosi

Placebo for recombinant human growth hormone + rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH + Rosi Placebo

Recombinant human growth hormone + placebo for rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Double Placebo

Placebo for recombinant human growth hormone + placebo for rosiglitazone

Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Total Total of all reporting groups

Baseline Measures
    rhGH + Rosi     rhGH Placebo + Rosi     rhGH + Rosi Placebo     Double Placebo     Total  
Number of Participants  
[units: participants]
  22     19     17     19     77  
Age  
[units: years]
Mean ± Standard Deviation
  46.8  ± 9.4     49.3  ± 6.1     48.6  ± 4.9     46.6  ± 6.7     47.9  ± 7.1  
Gender  
[units: participants]
         
Female     4     4     3     6     17  
Male     18     15     14     13     60  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     6     6     6     6     24  
White     15     11     11     12     49  
More than one race     1     2     0     1     4  
Unknown or Not Reported     0     0     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     9     9     3     9     30  
Not Hispanic or Latino     13     10     14     10     47  
Unknown or Not Reported     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   Change in Insulin Sensitivity   [ Time Frame: 12 weeks ]

2.  Secondary:   Change in Visceral Adipose Tissue Volume   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in Subcutaneous Adipose Tissue Volume   [ 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
No text entered.


  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. Marshall J. Glesby
Organization: Weill Cornell Medical College
phone: 212-746-4177
e-mail: mag2005@med.cornell.edu


Publications of Results:

Responsible Party: Marshall Jay Glesby, MD, PhD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00130286     History of Changes
Other Study ID Numbers: 65515, R01DK065515
Study First Received: August 12, 2005
Results First Received: December 16, 2013
Last Updated: February 10, 2014
Health Authority: United States: Federal Government