Physiologic Growth Hormone Effects in HIV Lipodystrophy

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: NCT00100698
Recruitment Status : Completed
First Posted : January 5, 2005
Results First Posted : July 22, 2010
Last Update Posted : July 27, 2010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: AIDS
HIV Infections
Interventions: Drug: recombinant human growth hormone
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
Patients with HIV and lipodystrophy were recruited between November 2003 and March 2006 via community advertisement, HIV support and advocacy groups, and infectious disease or primary care physician referral.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.

Reporting Groups
Recombinant Human Growth Hormone recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
Placebo placebo subcutaneously once a day

Participant Flow:   Overall Study
    Recombinant Human Growth Hormone   Placebo
STARTED   27   29 
COMPLETED   21   27 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Change in Visceral Adipose Tissue Area From Baseline to 18 Months   [ Time Frame: 18 months ]

2.  Secondary:   Change in Insulin-like Growth Factor-I From Baseline to 18 Months   [ Time Frame: 18 months ]

3.  Secondary:   Change in Trunk Fat   [ Time Frame: 18 months ]

4.  Secondary:   Change in Fasting Glucose   [ Time Frame: 18 months ]

5.  Secondary:   Change in Trunk to Extremity Ratio   [ Time Frame: 18 months ]

6.  Secondary:   Change in Triglycerides   [ Time Frame: 18 months ]

7.  Secondary:   Change in Subcutaneous Adipose Tissue   [ Time Frame: 18 months ]

8.  Secondary:   Change in CD4 Cells   [ Time Frame: 18 months ]

9.  Secondary:   Change in Logarithm HIV Viral Load   [ Time Frame: 18 months ]

10.  Secondary:   Change in Lean Body Mass   [ Time Frame: 18 months ]

11.  Secondary:   Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months   [ Time Frame: 18 months ]

12.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: 18 months ]

13.  Secondary:   Change in Adiponectin   [ Time Frame: 18 months ]

14.  Secondary:   Change in Carotid Intima Media Thickness (IMT)   [ Time Frame: 18 months ]

15.  Secondary:   Change in Body Mass Index   [ Time Frame: 18 months ]

16.  Secondary:   Change in Extremity Fat   [ Time Frame: 18 months ]

17.  Secondary:   Change in 2-hour Glucose   [ Time Frame: 18 months ]

18.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: 18 months ]

  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
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  More Information