Trial · NCT01263717

Effects of Growth Hormone Releasing Hormone in HIV

NCT01263717, Not applicable, Completed, Massachusetts General Hospital; results first posted 2014-10-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Growth Hormone Releasing Hormone in HIV. Trials, record NCT01263717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263717

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Growth Hormone Releasing Hormone in HIV
NCT number: NCT01263717
Status: Completed
Phases: Not applicable
Enrollment: 54 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: HIV, HIV Lipodystrophy
Interventions: tesamorelin, placebo
First posted: 2010-12-21
Last updated: 2017-10-30
Results first posted: 2014-10-13
Limitations and caveats: Please note that we intended to collect and analyze data on PAI1 and tPA but we did not have sufficient funds to do this.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Liver Fat	6 months	Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).
Primary	Visceral Adipose Tissue	6 months	Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.
Secondary	Intramyocellular Lipid	6 months	Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.
Secondary	Endogenous Growth Hormone Secretion	6 months	Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.
Secondary	Insulin Sensitivity	6 months	In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.
Secondary	HbA1c	6 months	Hemoglobin A1c.
Secondary	Insulin Like Growth Factor 1 (IGF-I)	6 months	Insulin Like Growth Factor 1 (IGF-I).
Secondary	Lipid Panel	6 months	Fasting lipids. Triglyceride value is given.
Secondary	Carotid Intimal Medial Thickness (cIMT)	6 months	Carotid Intimal Medial Thickness (cIMT).
Secondary	Glucose Tolerance	6 months	Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Liver Fat	6 months	All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.	Change in hepatic lipid-to-water %	MEDIAN
PRIMARY	Visceral Adipose Tissue	6 months	Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.	change in cm^2 after 6 months	MEAN
SECONDARY	Intramyocellular Lipid	6 months	All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.	Change in ratio of IMCL/Cr	MEDIAN
SECONDARY	Endogenous Growth Hormone Secretion	6 months	All available data were used; data were not available for some subjects.	Change in ng/mL	MEDIAN
SECONDARY	Insulin Sensitivity	6 months	All available data were used; data were not available for some subjects.	Change in mg/kg/min	MEAN
SECONDARY	HbA1c	6 months	All available data were used; data were not available for one subject.	Change in %	MEAN
SECONDARY	Insulin Like Growth Factor 1 (IGF-I)	6 months	All available data were used; data were not available for one subject.	Change in ng/mL	MEAN
SECONDARY	Lipid Panel	6 months	All available data were used; data were not available for one subject.	Change in triglyceride, mg/dL	MEDIAN
SECONDARY	Carotid Intimal Medial Thickness (cIMT)	6 months	All available data were used.	Change in mm	MEAN
SECONDARY	Glucose Tolerance	6 months	All available data were used; data were not available for some subjects.	Change in 2-hour glucose, mg/dL	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Liver Fat	Tesamorelin	-2.0	Inter-Quartile Range -6.4 to 0.1	Change in hepatic lipid-to-water %
Liver Fat	Placebo (Inactive Injection)	0.9	Inter-Quartile Range -0.6 to 3.7	Change in hepatic lipid-to-water %
Visceral Adipose Tissue	Tesamorelin	-34	95% Confidence Interval -53 to -15	change in cm^2 after 6 months
Visceral Adipose Tissue	Placebo (Inactive Injection)	8	95% Confidence Interval -14 to 30	change in cm^2 after 6 months
Intramyocellular Lipid	Tesamorelin	-1.7	Inter-Quartile Range -3.9 to 0.7	Change in ratio of IMCL/Cr
Intramyocellular Lipid	Placebo (Inactive Injection)	-0.2	Inter-Quartile Range -5.2 to 5.5	Change in ratio of IMCL/Cr
Endogenous Growth Hormone Secretion	Tesamorelin	0.35	Inter-Quartile Range 0.15 to 0.57	Change in ng/mL
Endogenous Growth Hormone Secretion	Placebo (Inactive Injection)	-0.01	Inter-Quartile Range -0.07 to 0.06	Change in ng/mL
Insulin Sensitivity	Tesamorelin	0.4	95% Confidence Interval -1.2 to 1.9	Change in mg/kg/min
Insulin Sensitivity	Placebo (Inactive Injection)	0.7	95% Confidence Interval -0.6 to 2.1	Change in mg/kg/min

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tesamorelin	28
Overall Study	STARTED	Placebo (Inactive Injection)	26
Overall Study	Baseline Visit	Tesamorelin	28
Overall Study	Baseline Visit	Placebo (Inactive Injection)	22
Overall Study	COMPLETED	Tesamorelin	23
Overall Study	COMPLETED	Placebo (Inactive Injection)	20
Overall Study	NOT COMPLETED	Tesamorelin	5
Overall Study	NOT COMPLETED	Placebo (Inactive Injection)	6

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	injection site bruising	Skin and subcutaneous tissue disorders	Tesamorelin	10	28
other	injection site bruising	Skin and subcutaneous tissue disorders	Placebo (Inactive Injection)	11	22
other	paresthesia	Nervous system disorders	Tesamorelin	6	28
other	paresthesia	Nervous system disorders	Placebo (Inactive Injection)	1	22
other	erythema at injection site	Skin and subcutaneous tissue disorders	Tesamorelin	4	28
other	erythema at injection site	Skin and subcutaneous tissue disorders	Placebo (Inactive Injection)	2	22
other	joint pain	Musculoskeletal and connective tissue disorders	Tesamorelin	4	28
other	joint pain	Musculoskeletal and connective tissue disorders	Placebo (Inactive Injection)	4	22
other	stinging of skin	Skin and subcutaneous tissue disorders	Tesamorelin	3	28
other	stinging of skin	Skin and subcutaneous tissue disorders	Placebo (Inactive Injection)	0	22

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tesamorelin
Total, all-cause mortality	Placebo (Inactive Injection)
Total, other adverse events	Tesamorelin	25	28
Total, other adverse events	Placebo (Inactive Injection)	21	22
Total, serious adverse events	Tesamorelin	3	28
Total, serious adverse events	Placebo (Inactive Injection)	3	22

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25038357	RESULT	PubMed
29031905	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Tesamorelin vs Placebo (Inactive Injection): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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