Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00130286
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 77
• Locations: 4
• Arms: 4
• Duration (Months): 65
• Patients Per Site: 19.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.

Condition or Disease	Intervention/Treatment	Phase
HIV-Associated Lipodystrophy Syndrome; Insulin Resistance; HIV Infections; Metabolic Syndrome X; Body Weight Changes	Drug: Rosiglitazone; Drug: Recombinant human growth hormone + rosiglitazone	Phase 1/Phase 2

Detailed Description

A number of people with HIV infection who gain weight in the abdomen (sometimes called lipodystrophy) also have a high level of the sugar-controlling hormone called insulin. These people need to produce this extra insulin to help keep their blood sugar normal. This is called "insulin resistance."

Studies have shown that growth hormone (also called "Serostim") can decrease abdominal fat, but it can also worsen the insulin resistance. Rosiglitazone (also called "Avandia") is used to treat insulin resistance in people who have diabetes, so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy.

The study is 24 weeks long, divided into two 12-week parts.

The first part of the study is double-blind, meaning that neither participants nor the study staff will know which drugs participants are on. Participants will be assigned randomly (like flipping a coin) to one of four groups:

1. Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).

2. Growth hormone PLUS rosiglitazone placebo ("sugar pill").

3. Growth hormone placebo (plain water injection) PLUS rosiglitazone.

4. Growth hormone placebo PLUS rosiglitazone placebo.

Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12.

The second part of the study is open-label, meaning that participants and the study staff will know which drugs participants are receiving. All volunteers will receive both active drugs:

• Growth hormone (one 2 mg injection, every other day) PLUS rosiglitazone (one 4 mg tablet, twice daily).

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhGH + rosi Recombinant human growth hormone + rosiglitazone	Drug: Rosiglitazone; 4 mg tablet twice a day x 12 weeks (double-blind phase); Drug: Recombinant human growth hormone + rosiglitazone; Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Experimental: rhGH placebo + rosi Placebo for recombinant human growth hormone + rosiglitazone	Drug: Rosiglitazone; 4 mg tablet twice a day x 12 weeks (double-blind phase); Drug: Recombinant human growth hormone + rosiglitazone; Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Experimental: rhGH + rosi placebo Recombinant human growth hormone + placebo for rosiglitazone	Drug: Rosiglitazone; 4 mg tablet twice a day x 12 weeks (double-blind phase); Drug: Recombinant human growth hormone + rosiglitazone; Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Placebo Comparator: Double placebo Placebo for recombinant human growth hormone + placebo for rosiglitazone	Drug: Rosiglitazone; 4 mg tablet twice a day x 12 weeks (double-blind phase); Drug: Recombinant human growth hormone + rosiglitazone; Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Outcome Measures

Primary Outcome Measures

1. Change in Insulin Sensitivity [12 weeks]

   Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.

Secondary Outcome Measures

1. Change in Visceral Adipose Tissue Volume [12 weeks]

   Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.

2. Change in Subcutaneous Adipose Tissue Volume [12 weeks]

   Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV-infected

• On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks

• Excess abdominal fat based on waist and hip measurements done at the screening visit. [waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)]

• Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening)

• Triglycerides less than 750 mg/dL

Exclusion Criteria:

• Pregnancy

• Active AIDS-defining infection or other acute illness, within 30 days of entry.

• Active cancer (except for localized Kaposi's sarcoma) or active brain tumor

• Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure)

• Untreated or uncontrolled high blood pressure, within 30 days of entry.

• Within 12 weeks of study entry, use of the following:

• Obesity (fat-reducing) drugs.

• Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin).

• Systemic glucocorticoids (example: prednisone).

• Growth hormone or any medication for AIDS-associated wasting.

• Systemic chemotherapy, interferon, or radiation therapy.

• Androgenic agents [examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)]

• Appetite stimulants (Marinol, Megace, Periactin).

• Use of cholesterol lowering drugs, unless started more than 12 weeks before entry

• Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIDS Community Research Initiative of America (ACRIA)	New York	New York	United States	10018
2	Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University	New York	New York	United States	10021
3	St. Luke's-Roosevelt Hospital Center	New York	New York	United States	10025
4	Columbia University College of Physicians and Surgeons	New York	New York	United States	10032

Sponsors and Collaborators

• Weill Medical College of Cornell University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Marshall J Glesby, MD, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marshall Jay Glesby, MD, PhD, Professor of Medicine and Public Health, Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00130286
• Other Study ID Numbers: 65515; R01DK065515
• First Posted: Aug 15, 2005
• Last Update Posted: Feb 13, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Marshall Jay Glesby, MD, PhD, Professor of Medicine and Public Health, Weill Medical College of Cornell University: Lipodystrophy; HIV; Growth hormone; Rosiglitazone; Visceral fat; Metabolic syndrome; Treatment Experienced; Visceral fat accumulation; fat accumulation; HIV-Associated Metabolic Syndrome
• Additional relevant MeSH terms: HIV-Associated Lipodystrophy Syndrome; Lipodystrophy; Metabolic Syndrome; Insulin Resistance; Syndrome; Body Weight; Body Weight Changes; Rosiglitazone; Hormones

Study Results

Participant Flow

Arm/Group Title	rhGH + Rosi	rhGH Placebo + Rosi	rhGH + Rosi Placebo	Double Placebo
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Period Title: Overall Study
STARTED	22	19	17	19
COMPLETED	22	16	13	17
NOT COMPLETED	0	3	4	2

Baseline Characteristics

Arm/Group Title	rhGH + Rosi	rhGH Placebo + Rosi	rhGH + Rosi Placebo	Double Placebo	Total
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Total of all reporting groups
Overall Participants	22	19	17	19	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.8 (9.4)	49.3 (6.1)	48.6 (4.9)	46.6 (6.7)	47.9 (7.1)
Sex: Female, Male (Count of Participants)
Female	4 18.2%	4 21.1%	3 17.6%	6 31.6%	17 22.1%
Male	18 81.8%	15 78.9%	14 82.4%	13 68.4%	60 77.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	6 27.3%	6 31.6%	6 35.3%	6 31.6%	24 31.2%
White	15 68.2%	11 57.9%	11 64.7%	12 63.2%	49 63.6%
More than one race	1 4.5%	2 10.5%	0 0%	1 5.3%	4 5.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 40.9%	9 47.4%	3 17.6%	9 47.4%	30 39%
Not Hispanic or Latino	13 59.1%	10 52.6%	14 82.4%	10 52.6%	47 61%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Insulin Sensitivity
Description	Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhGH + Rosi	rhGH Placebo + Rosi	rhGH + Rosi Placebo	Double Placebo
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Measure Participants	22	16	13	17
Median (Inter-Quartile Range) [uU*10^-4*min*ml^-1]	0.20	1.44	-0.63	0.14

2. Secondary Outcome

Title	Change in Visceral Adipose Tissue Volume
Description	Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhGH + Rosi	rhGH Placebo + Rosi	rhGH + Rosi Placebo	Double Placebo
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Measure Participants	20	15	11	16
Mean (Standard Deviation) [L]	-1.13 (1.41)	-0.19 (0.69)	-1.15 (0.81)	-0.04 (0.9)

3. Secondary Outcome

Title	Change in Subcutaneous Adipose Tissue Volume
Description	Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhGH + Rosi	rhGH Placebo + Rosi	rhGH + Rosi Placebo	Double Placebo
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Measure Participants	20	15	11	16
Mean (Standard Deviation) [L]	-0.11 (3.33)	0.74 (1.86)	-0.38 (1.23)	-0.03 (2.64)

Adverse Events

Adverse Event Reporting Description	The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
Arm/Group Title	rhGH + Rosi		rhGH Placebo + Rosi		rhGH + Rosi Placebo		Double Placebo
Arm/Group Description	Recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)		Placebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)		Recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)		Placebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
All Cause Mortality
	rhGH + Rosi		rhGH Placebo + Rosi		rhGH + Rosi Placebo		Double Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	rhGH + Rosi		rhGH Placebo + Rosi		rhGH + Rosi Placebo		Double Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		1/19 (5.3%)		0/17 (0%)		3/19 (15.8%)
Infections and infestations
Fever of undetermined origin	0/22 (0%)	0	0/19 (0%)	0	0/17 (0%)	0	1/19 (5.3%)	1
Injury, poisoning and procedural complications
Study drug overdose	0/22 (0%)	0	1/19 (5.3%)	1	0/17 (0%)	0	0/19 (0%)	0
Nervous system disorders
Delirium	1/22 (4.5%)	1	0/19 (0%)	0	0/17 (0%)	0	0/19 (0%)	0
Leg weakness and pain	0/22 (0%)	0	0/19 (0%)	0	0/17 (0%)	0	1/19 (5.3%)	1
Renal and urinary disorders
Ureteral obstruction	0/22 (0%)	0	0/19 (0%)	0	0/17 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	rhGH + Rosi		rhGH Placebo + Rosi		rhGH + Rosi Placebo		Double Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/22 (77.3%)		11/18 (61.1%)		14/15 (93.3%)		9/17 (52.9%)
Endocrine disorders
Hyperglycemia	5/22 (22.7%)		1/18 (5.6%)		8/15 (53.3%)		2/17 (11.8%)
Gastrointestinal disorders
Nausea	2/22 (9.1%)		0/18 (0%)		0/15 (0%)		1/17 (5.9%)
Vomiting	0/22 (0%)		1/18 (5.6%)		0/15 (0%)		3/17 (17.6%)
Abdominal pain	0/22 (0%)		1/18 (5.6%)		2/15 (13.3%)		1/17 (5.9%)
General disorders
Fever	0/22 (0%)		1/18 (5.6%)		1/15 (6.7%)		2/17 (11.8%)
Fatigue	7/22 (31.8%)		6/18 (33.3%)		5/15 (33.3%)		5/17 (29.4%)
Weight gain	1/22 (4.5%)		0/18 (0%)		1/15 (6.7%)		2/17 (11.8%)
Headache	3/22 (13.6%)		2/18 (11.1%)		3/15 (20%)		2/17 (11.8%)
Cough/upper respiratory infection	0/22 (0%)		0/18 (0%)		2/15 (13.3%)		2/17 (11.8%)
Hepatobiliary disorders
Increased ALT	2/22 (9.1%)		2/18 (11.1%)		0/15 (0%)		0/17 (0%)
Increased AST	1/22 (4.5%)		2/18 (11.1%)		1/15 (6.7%)		1/17 (5.9%)
Metabolism and nutrition disorders
Hypertriglyceridemia	0/22 (0%)		1/18 (5.6%)		2/15 (13.3%)		3/17 (17.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/22 (31.8%)		4/18 (22.2%)		5/15 (33.3%)		5/17 (29.4%)
Carpal tunnel syndrome	1/22 (4.5%)		1/18 (5.6%)		3/15 (20%)		0/17 (0%)
Myalgia	6/22 (27.3%)		4/18 (22.2%)		6/15 (40%)		3/17 (17.6%)
Back pain	4/22 (18.2%)		4/18 (22.2%)		4/15 (26.7%)		2/17 (11.8%)
Edema	12/22 (54.5%)		3/18 (16.7%)		11/15 (73.3%)		2/17 (11.8%)
Nervous system disorders
Parethesias	5/22 (22.7%)		1/18 (5.6%)		4/15 (26.7%)		2/17 (11.8%)
Reproductive system and breast disorders
Breast enlargement/tenderness	4/22 (18.2%)		1/18 (5.6%)		0/15 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.