HIV-Associated Lipodystrophy SyndromePhase 1/2NCT00130286

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

A Phase 1/2 study testing Rosiglitazone and Recombinant human growth hormone + rosiglitazone in people with HIV-Associated Lipodystrophy Syndrome and Insulin Resistance, run by Weill Medical College of Cornell University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections
What is being tested?: Rosiglitazone and Recombinant human growth hormone + rosiglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 4 sitesUnited States
Study dates: Mar 2005to Aug 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:

Show all 15Show fewer

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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

AIDS Community Research Initiative of America (ACRIA)
New York, New York, 10018
Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
New York, New York, 10021
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
Columbia University College of Physicians and Surgeons
New York, New York, 10032

Other trials in United States

About this study

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

Read the 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:

Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).
Growth hormone PLUS rosiglitazone placebo ("sugar pill").
Growth hormone placebo (plain water injection) PLUS rosiglitazone.
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).

Conditions: HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome X, Body Weight Changes
Being tested: Rosiglitazone, Recombinant human growth hormone + rosiglitazone
Keywords: Lipodystrophy, HIV, Growth hormone, Rosiglitazone, Visceral fat, Metabolic syndrome, Treatment Experienced, Visceral fat accumulation, fat accumulation, HIV-Associated Metabolic Syndrome
Medical subject headings: HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome, Body Weight Changes, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosiglitazoneDrug
4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazoneDrug
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Study groups in NCT00130286
Study group	Role	What they receive
rhGH + rosi	Experimental	Recombinant human growth hormone + rosiglitazone Receives: Drug: Rosiglitazone; Drug: Recombinant human growth hormone + rosiglitazone
rhGH placebo + rosi	Experimental	Placebo for recombinant human growth hormone + rosiglitazone Receives: Drug: Rosiglitazone; Drug: Recombinant human growth hormone + rosiglitazone
rhGH + rosi placebo	Experimental	Recombinant human growth hormone + placebo for rosiglitazone Receives: Drug: Rosiglitazone; Drug: Recombinant human growth hormone + rosiglitazone
Double placebo	Placebo comparator	Placebo for recombinant human growth hormone + placebo for rosiglitazone Receives: Drug: Rosiglitazone; Drug: Recombinant human growth hormone + rosiglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insulin Sensitivity
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.
Measured: 12 weeks

Secondary outcomes (2)

Change in Visceral Adipose Tissue Volume
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.
Measured: 12 weeks
Change in Subcutaneous Adipose Tissue Volume
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Aug 2010

First posted15 Aug 2005 (estimated)
Study startMar 2005
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV-Associated Lipodystrophy SyndromeStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00130286
Sponsor's protocol ID: 65515
Other IDs: R01DK065515
Status last verified: Feb 2014
First submitted: 12 Aug 2005
Last updated: 13 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Glesby MJ, Albu J, Chiu YL, Ham K, Engelson E, He Q, Muthukrishnan V, Ginsberg HN, Donovan D, Ernst J, Lesser M, Kotler DP. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial. PLoS One. 2013 Apr 12;8(4):e61160. doi: 10.1371/journal.pone.0061160. Print 2013.
PubMed 23593417
Kotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016;21(2):107-16. doi: 10.3851/IMP2927. Epub 2014 Dec 23.
PubMed 25536669

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00130286
Acronym / sponsor ID: 65515
Conditions: HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome X, Body Weight Changes
Keywords: Lipodystrophy, HIV, Growth hormone, Rosiglitazone, Visceral fat, Metabolic syndrome, Treatment Experienced, Visceral fat accumulation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Mar 2005
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 15 Aug 2005 (estimated)
Results: Posted 13 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).
Growth hormone PLUS rosiglitazone placebo ("sugar pill").
Growth hormone placebo (plain water injection) PLUS rosiglitazone.
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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
rhGH + rosi	Experimental	Drug: Rosiglitazone, Drug: Recombinant human growth hormone + rosiglitazoneRecombinant human growth hormone + rosiglitazone
rhGH placebo + rosi	Experimental	Drug: Rosiglitazone, Drug: Recombinant human growth hormone + rosiglitazonePlacebo for recombinant human growth hormone + rosiglitazone
rhGH + rosi placebo	Experimental	Drug: Rosiglitazone, Drug: Recombinant human growth hormone + rosiglitazoneRecombinant human growth hormone + placebo for rosiglitazone
Double placebo	Placebo comparator	Drug: Rosiglitazone, Drug: Recombinant human growth hormone + rosiglitazonePlacebo for recombinant human growth hormone + placebo for rosiglitazone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rosiglitazone4 mg tablet twice a day x 12 weeks (double-blind phase)	Drug	Double placebo, rhGH + rosi, rhGH + rosi placebo, rhGH placebo + rosi
Recombinant human growth hormone + rosiglitazoneRecombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)	Drug	Double placebo, rhGH + rosi, rhGH + rosi placebo, rhGH placebo + rosi

Primary outcome

Change in Insulin Sensitivity
Time frame: 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.

2 secondary outcomes

Change in Visceral Adipose Tissue Volume
Time frame: 12 weeks
Change in Subcutaneous Adipose Tissue Volume
Time frame: 12 weeks

Results and safety

Results posted to the registry on 13 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rhGH + Rosi	22	22
rhGH Placebo + Rosi	19	16
rhGH + Rosi Placebo	17	13
Double Placebo	19	17

Primary outcome: Change in Insulin Sensitivity

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: uU*10^-4*min*ml^-1

Measure	rhGH + Rosi n = 22	rhGH Placebo + Rosi n = 16	rhGH + Rosi Placebo n = 13	Double Placebo n = 17
Value	0.20 (-0.37 to 1.00)	1.44 (0.68 to 2.59)	-0.63 (-1.03 to 0.11)	0.14 (-0.41 to 1.21)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rhGH + Rosi	1 of 22 (4.5%)	17 of 22 (77.3%)	Not reported
rhGH Placebo + Rosi	1 of 19 (5.3%)	11 of 18 (61.1%)	Not reported
rhGH + Rosi Placebo	0 of 17 (0%)	14 of 15 (93.3%)	Not reported
Double Placebo	3 of 19 (15.8%)	9 of 17 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23593417Glesby MJ, Albu J, Chiu YL, Ham K, Engelson E, He Q, Muthukrishnan V, Ginsberg HN, Donovan D, Ernst J, Lesser M, Kotler DP. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial. PLoS One. 2013 Apr 12;8(4):e61160. doi: 10.1371/journal.pone.0061160. Print 2013.
Derived from this study: PubMed 25536669Kotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016;21(2):107-16. doi: 10.3851/IMP2927. Epub 2014 Dec 23.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marshall J Glesby, MD, PhD principal investigator

Weill Medical College of Cornell University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insulin Sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130286, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.