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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.
 
ClinicalTrials.gov Identifier: NCT00100698
Recruitment Status : Completed
First Posted : January 5, 2005
Results First Posted : July 22, 2010
Last Update Posted : July 27, 2010
Sponsor:
Collaborator:
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
Enrollment 56
Recruitment Details 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 Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously placebo subcutaneously once a day
Period Title: Overall Study
Started 27 29
Completed 21 27
Not Completed 6 2
Arm/Group Title Recombinant Human Growth Hormone Placebo Total
Hide Arm/Group Description recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously placebo subcutaneously once a day Total of all reporting groups
Overall Number of Baseline Participants 27 29 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
29
 100.0%
56
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 29 participants 56 participants
46.7  (7.9) 47.4  (6.1) 47.1  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 56 participants
Female
1
   3.7%
3
  10.3%
4
   7.1%
Male
26
  96.3%
26
  89.7%
52
  92.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 29 participants 56 participants
27 29 56
1.Primary Outcome
Title Change in Visceral Adipose Tissue Area From Baseline to 18 Months
Hide Description change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: centimeters squared
-22  (6) -4  (4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombinant Human Growth Hormone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method repeated measures mixed effects ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -22
Confidence Interval (2-Sided) 95%
-38 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Insulin-like Growth Factor-I From Baseline to 18 Months
Hide Description Change in insulin-like growth factor-1
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: nanograms/milliliter
109  (11) -25  (8)
3.Secondary Outcome
Title Change in Trunk Fat
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: kilograms
-0.5  (0.2) 0.2  (0.2)
4.Secondary Outcome
Title Change in Fasting Glucose
Hide Description change in fasting glucose
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: mg/dL
6  (1) 5  (1)
5.Secondary Outcome
Title Change in Trunk to Extremity Ratio
Hide Description change in trunk to extremity ratio
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: kilogram per kilogram
-0.4  (0.1) 0  (0)
6.Secondary Outcome
Title Change in Triglycerides
Hide Description Change in triglycerides
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-7
(-43 to 41)
0
(-56 to 51)
7.Secondary Outcome
Title Change in Subcutaneous Adipose Tissue
Hide Description Change in subcutaneous adipose tissue
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: centimeters squared
4  (4) 4  (4)
8.Secondary Outcome
Title Change in CD4 Cells
Hide Description Change in CD4 cells
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: cells/microliter
-19  (13) 15  (21)
9.Secondary Outcome
Title Change in Logarithm HIV Viral Load
Hide Description Change in logarithm base 10 HIV viral load
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: log base 10 copies of RNA/milliliter
0  (0.1) 0  (0.2)
10.Secondary Outcome
Title Change in Lean Body Mass
Hide Description change in lean body mass
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: kilograms
0.8  (0.3) -0.5  (0.3)
11.Secondary Outcome
Title Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
Hide Description Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: units on a scale
-4  (3) -4  (3)
12.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Change in diastolic blood pressure
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: mm Hg
-3  (1) 4  (1)
13.Secondary Outcome
Title Change in Adiponectin
Hide Description Change in adiponectin
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: mcg/mL
1.0  (0.3) 0.5  (0.1)
14.Secondary Outcome
Title Change in Carotid Intima Media Thickness (IMT)
Hide Description change in carotid intima media thickness (IMT)
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: millimeter
0.003  (0.008) -0.003  (0.009)
15.Secondary Outcome
Title Change in Body Mass Index
Hide Description Change in body mass index
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: kilogram/meters squared
0.2  (0.2) 0.1  (0.1)
16.Secondary Outcome
Title Change in Extremity Fat
Hide Description Change in extremity fat
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: kilograms
0.3  (0.1) 0.3  (0.1)
17.Secondary Outcome
Title Change in 2-hour Glucose
Hide Description Change in 2-hour glucose
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: mg/dL
16  (5) -4  (4)
18.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in systolic blood pressure
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description:
recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
placebo subcutaneously once a day
Overall Number of Participants Analyzed 27 29
Mean (Standard Error)
Unit of Measure: mm Hg
-5  (2) 1  (2)
Time Frame 18 months
Adverse Event Reporting Description 1 participant in the growth hormone group dropped out of the study before ever receiving study drug and therefore was not included in the adverse event safety analysis.
 
Arm/Group Title Recombinant Human Growth Hormone Placebo
Hide Arm/Group Description recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously placebo subcutaneously once a day
All-Cause Mortality
Recombinant Human Growth Hormone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Recombinant Human Growth Hormone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/26 (15.38%)      1/29 (3.45%)    
Gastrointestinal disorders     
appendicitis requiring surgery *  1/26 (3.85%)  1 0/29 (0.00%)  0
Infections and infestations     
hospitalization * [1]  1/26 (3.85%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
hip fracture requiring surgery * [2]  1/26 (3.85%)  1 0/29 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
rectal cancer *  1/26 (3.85%)  1 0/29 (0.00%)  0
anal cancer *  0/26 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
[1]
hospitalization for confusion and transaminitis thought to be related to HIV disease progression
[2]
hip fracture requiring surgery
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recombinant Human Growth Hormone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/26 (11.54%)      5/29 (17.24%)    
Endocrine disorders     
hyperglycemia   0/26 (0.00%)  0 2/29 (6.90%)  2
Musculoskeletal and connective tissue disorders     
arthralgia   0/26 (0.00%)  0 2/29 (6.90%)  2
Nervous system disorders     
tingling and paresthesia   3/26 (11.54%)  3 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Janet Lo
Organization: Massachusetts General Hospital
Phone: 617-724-9109
EMail: jlo@partners.org
Layout table for additonal information
Responsible Party: Steven Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00100698    
Other Study ID Numbers: DK63639
R01DK063639 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2005
First Posted: January 5, 2005
Results First Submitted: April 9, 2010
Results First Posted: July 22, 2010
Last Update Posted: July 27, 2010