Trial Outcomes & Findings for Physiologic Growth Hormone Effects in HIV Lipodystrophy (NCT NCT00100698)

NCT ID: NCT00100698

Last Updated: 2010-07-27

Results Overview

change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2010-07-27

Participant Flow

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.

Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.

Participant milestones

Measure	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
Overall Study STARTED	27	29
Overall Study COMPLETED	21	27
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physiologic Growth Hormone Effects in HIV Lipodystrophy

Baseline characteristics by cohort

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	46.7 years STANDARD_DEVIATION 7.9 • n=5 Participants	47.4 years STANDARD_DEVIATION 6.1 • n=7 Participants	47.1 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	29 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Visceral Adipose Tissue Area From Baseline to 18 Months	-22 centimeters squared Standard Error 6	-4 centimeters squared Standard Error 4

SECONDARY outcome

Timeframe: 18 months

Change in insulin-like growth factor-1

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Insulin-like Growth Factor-I From Baseline to 18 Months	109 nanograms/milliliter Standard Error 11	-25 nanograms/milliliter Standard Error 8

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Trunk Fat	-0.5 kilograms Standard Error 0.2	0.2 kilograms Standard Error 0.2

SECONDARY outcome

Timeframe: 18 months

change in fasting glucose

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Fasting Glucose	6 mg/dL Standard Error 1	5 mg/dL Standard Error 1

SECONDARY outcome

Timeframe: 18 months

change in trunk to extremity ratio

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Trunk to Extremity Ratio	-0.4 kilogram per kilogram Standard Error 0.1	0 kilogram per kilogram Standard Error 0

SECONDARY outcome

Timeframe: 18 months

Change in triglycerides

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Triglycerides	-7 mg/dL Interval -43.0 to 41.0	0 mg/dL Interval -56.0 to 51.0

SECONDARY outcome

Timeframe: 18 months

Change in subcutaneous adipose tissue

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Subcutaneous Adipose Tissue	4 centimeters squared Standard Error 4	4 centimeters squared Standard Error 4

SECONDARY outcome

Timeframe: 18 months

Change in CD4 cells

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in CD4 Cells	-19 cells/microliter Standard Error 13	15 cells/microliter Standard Error 21

SECONDARY outcome

Timeframe: 18 months

Change in logarithm base 10 HIV viral load

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Logarithm HIV Viral Load	0 log base 10 copies of RNA/milliliter Standard Error 0.1	0 log base 10 copies of RNA/milliliter Standard Error 0.2

SECONDARY outcome

Timeframe: 18 months

change in lean body mass

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Lean Body Mass	0.8 kilograms Standard Error 0.3	-0.5 kilograms Standard Error 0.3

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months	-4 units on a scale Standard Error 3	-4 units on a scale Standard Error 3

SECONDARY outcome

Timeframe: 18 months

Change in diastolic blood pressure

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Diastolic Blood Pressure	-3 mm Hg Standard Error 1	4 mm Hg Standard Error 1

SECONDARY outcome

Timeframe: 18 months

Change in adiponectin

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Adiponectin	1.0 mcg/mL Standard Error 0.3	0.5 mcg/mL Standard Error 0.1

SECONDARY outcome

Timeframe: 18 months

change in carotid intima media thickness (IMT)

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Carotid Intima Media Thickness (IMT)	0.003 millimeter Standard Error 0.008	-0.003 millimeter Standard Error 0.009

SECONDARY outcome

Timeframe: 18 months

Change in body mass index

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Body Mass Index	0.2 kilogram/meters squared Standard Error 0.2	0.1 kilogram/meters squared Standard Error 0.1

SECONDARY outcome

Timeframe: 18 months

Change in extremity fat

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Extremity Fat	0.3 kilograms Standard Error 0.1	0.3 kilograms Standard Error 0.1

SECONDARY outcome

Timeframe: 18 months

Change in 2-hour glucose

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in 2-hour Glucose	16 mg/dL Standard Error 5	-4 mg/dL Standard Error 4

SECONDARY outcome

Timeframe: 18 months

Change in systolic blood pressure

Outcome measures

Measure	Recombinant Human Growth Hormone n=27 Participants recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 Participants placebo subcutaneously once a day
Change in Systolic Blood Pressure	-5 mm Hg Standard Error 2	1 mm Hg Standard Error 2

Adverse Events

Recombinant Human Growth Hormone

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Recombinant Human Growth Hormone n=26 participants at risk recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 participants at risk placebo subcutaneously once a day
Neoplasms benign, malignant and unspecified (incl cysts and polyps) rectal cancer	3.8% 1/26 • Number of events 1 • 18 months 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.	0.00% 0/29 • 18 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) anal cancer	0.00% 0/26 • 18 months 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.	3.4% 1/29 • Number of events 1 • 18 months 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.
Infections and infestations hospitalization	3.8% 1/26 • Number of events 1 • 18 months 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.	0.00% 0/29 • 18 months 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.
Musculoskeletal and connective tissue disorders hip fracture requiring surgery	3.8% 1/26 • Number of events 1 • 18 months 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.	0.00% 0/29 • 18 months 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.
Gastrointestinal disorders appendicitis requiring surgery	3.8% 1/26 • Number of events 1 • 18 months 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.	0.00% 0/29 • 18 months 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.

Other adverse events

Measure	Recombinant Human Growth Hormone n=26 participants at risk recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously	Placebo n=29 participants at risk placebo subcutaneously once a day
Nervous system disorders tingling and paresthesia	11.5% 3/26 • Number of events 3 • 18 months 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.	3.4% 1/29 • Number of events 1 • 18 months 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.
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/26 • 18 months 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.	6.9% 2/29 • Number of events 2 • 18 months 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.
Endocrine disorders hyperglycemia	0.00% 0/26 • 18 months 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.	6.9% 2/29 • Number of events 2 • 18 months 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.

Additional Information

Janet Lo

Massachusetts General Hospital

Phone: 617-724-9109

Email: jlo@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place