Trial Outcomes & Findings for Effects of Short-term Growth Hormone in HIV-infected Patients (NCT NCT00795210)

Results Overview

Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

after 2 weeks treatment

Results posted on

2014-01-08

Participant Flow

Recruitment occurred between January, 2009 and November, 2012, in the Boston area.

Once patients were found to be eligible (after screen visit) and agreed to participate, there were no additional events prior to baseline.

Participant milestones

Participant milestones
Measure	GH 6mcg/kg/d Recombinant human growth hormone 6mcg/kg SC once daily	GH 2mg Daily Recombinant human growth hormone 2mg SC once daily	Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Overall Study STARTED	8	12	5
Overall Study COMPLETED	8	11	3
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Short-term Growth Hormone in HIV-infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GH 6mcg/kg/d n=8 Participants Recombinant human growth hormone 6mcg/kg SC once daily	GH 2mg Daily n=12 Participants Recombinant human growth hormone 2mg SC once daily	Growth Hormone Releasing Hormone n=5 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks	Total n=25 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	49 years STANDARD_DEVIATION 7 • n=5 Participants	49 years STANDARD_DEVIATION 6 • n=7 Participants	47 years STANDARD_DEVIATION 4 • n=5 Participants	48 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	12 participants n=7 Participants	5 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: after 2 weeks treatment

Population: Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.

Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.

Outcome measures

Outcome measures
Measure	GH 6mcg/kg/d n=7 Participants Recombinant human growth hormone 6mcg/kg SC once daily	GH 2mg Daily n=11 Participants Recombinant human growth hormone 2mg SC once daily	Growth Hormone Releasing Hormone n=3 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug	0.23 ng/mL Interval 0.08 to 0.68	0.07 ng/mL Interval 0.04 to 0.12	1.24 ng/mL Interval 0.76 to 1.52

SECONDARY outcome

Timeframe: after two weeks treatment

Population: Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.

insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given

Outcome measures

Outcome measures
Measure	GH 6mcg/kg/d n=8 Participants Recombinant human growth hormone 6mcg/kg SC once daily	GH 2mg Daily n=7 Participants Recombinant human growth hormone 2mg SC once daily	Growth Hormone Releasing Hormone n=3 Participants Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Insulin Sensitivity	9.0 mg/kg/min Standard Deviation 2.9	7.5 mg/kg/min Standard Deviation 3.2	9.9 mg/kg/min Standard Deviation 1.2

Adverse Events

GH 6mcg/kg/d

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GH 2mg Daily

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Growth Hormone Releasing Hormone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GH 6mcg/kg/d n=8 participants at risk Recombinant human growth hormone 6mcg/kg SC once daily	GH 2mg Daily n=11 participants at risk Recombinant human growth hormone 2mg SC once daily	Growth Hormone Releasing Hormone n=3 participants at risk Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Respiratory, thoracic and mediastinal disorders Sinus Infection	12.5% 1/8 • Number of events 1 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/11 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/3 • AE data were actively collected during the 4 weeks of the study period.
Musculoskeletal and connective tissue disorders Back Pain	12.5% 1/8 • Number of events 1 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/11 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/3 • AE data were actively collected during the 4 weeks of the study period.
Blood and lymphatic system disorders Edema/Extremity Swelling	0.00% 0/8 • AE data were actively collected during the 4 weeks of the study period.	18.2% 2/11 • Number of events 2 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/3 • AE data were actively collected during the 4 weeks of the study period.
Endocrine disorders hyperglycemia	0.00% 0/8 • AE data were actively collected during the 4 weeks of the study period.	18.2% 2/11 • Number of events 2 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/3 • AE data were actively collected during the 4 weeks of the study period.
Skin and subcutaneous tissue disorders injection site bruising	0.00% 0/8 • AE data were actively collected during the 4 weeks of the study period.	9.1% 1/11 • Number of events 1 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/3 • AE data were actively collected during the 4 weeks of the study period.
Nervous system disorders headache	0.00% 0/8 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/11 • AE data were actively collected during the 4 weeks of the study period.	33.3% 1/3 • Number of events 1 • AE data were actively collected during the 4 weeks of the study period.
Nervous system disorders dizziness	0.00% 0/8 • AE data were actively collected during the 4 weeks of the study period.	0.00% 0/11 • AE data were actively collected during the 4 weeks of the study period.	33.3% 1/3 • Number of events 1 • AE data were actively collected during the 4 weeks of the study period.

Additional Information

Steven Grinspoon, MD

Massachusetts General Hospital

Phone: 617-724-9109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place