HIV LipodystrophyPhase 1NCT01329744
Effects of IGF-I in HIV Metabolic Disease
A Phase 1 study testing mecasermin in people with HIV Lipodystrophy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Lipodystrophy
- What is being tested?
- mecasermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV positive with undetectable viral load
- No change in antiretrovirals for 3 months
- Evidence of lipoatrophy in the limbs, and face or gluteal area
- Dyslipidemia defined as:
- Fasting triglycerides > 200 OR
- HDL cholesterol < 40 mg/dL
Show all 9Show fewer
- Abnormal glucose homeostasis defined as:
- Fasting hyperinsulinemia > 20 uU/mL OR
- Fasting glucose 100-125 mg/dL, inclusive
Who cannot join
- Two consecutive viral >75 or > 50 copies/mL using the tests listed above
- Presence of AIDS wasting
- Change in antiretroviral medication (not dose) in the prior 3 months
- Coronary artery disease, cerebrovascular, or peripheral arterial disease
- Diabetes mellitus
- Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated
Show all 16Show fewer
- Malignancy
- Eating disorder
- Pregnancy (urine pregnancy test is required of all females)
- Previous liposuction or bariatric surgery
- Other systemic conditions or other disorders at the discretion of the investigators
- Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators
- Use of interferon within the past six months
- Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months
- Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil).
- Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
Read the detailed description
The main objectives of this study are the following:
- Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
- Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
- Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
- Conditions
- HIV Lipodystrophy
- Being tested
- mecasermin, Placebo control
- Keywords
- HIV lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mecaserminDrug
Also called Increlex
a subcutaneous injection twice a day
Placebo controlDrug
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Recombinant IGF-I Receives: Drug: mecasermin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat.
Measured: 24 weeks
Secondary outcomes (1)
Glucose Homeostasis
Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV LipodystrophyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy Kim, University of Texas Southwestern Medical Center
- Investigators
- Roy J Kim, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329744
- Sponsor's protocol ID
- 1K23DK080644-01A1
- Status last verified
- Mar 2016
- First submitted
- 4 Apr 2011
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
- ClinicalTrials.gov ID
- NCT01329744
- Acronym / sponsor ID
- 1K23DK080644-01A1
- Conditions
- HIV Lipodystrophy
- Keywords
- HIV lipodystrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
Detailed description
The main objectives of this study are the following:
- Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
- Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
- Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: mecaserminRecombinant IGF-I |
| Placebo | Placebo comparator | Drug: Placebo control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- HIV positive with undetectable viral load
- No change in antiretrovirals for 3 months
- Evidence of lipoatrophy in the limbs, and face or gluteal area
- Dyslipidemia defined as:
- Fasting triglycerides > 200 OR
Key exclusion criteria (16 listed)
- Two consecutive viral >75 or > 50 copies/mL using the tests listed above
- Presence of AIDS wasting
- Change in antiretroviral medication (not dose) in the prior 3 months
- Coronary artery disease, cerebrovascular, or peripheral arterial disease
- Diabetes mellitus
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 |
|---|---|---|
| mecaserminAlso: Increlexa subcutaneous injection twice a day | Drug | Treatment |
| Placebo controlSubcutaneous injection given twice per day of placebo compound, for 24 weeks | Drug | Placebo |
Primary outcome
Body composition
Time frame: 24 weeks
Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat.
1 secondary outcome
Glucose Homeostasis
Time frame: 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
Related trials for HIV Lipodystrophy
RecruitingObservational study
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes
Lipodystrophy (Genetic or Acquired, Non HIV)
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.
Roy J Kim, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mecasermin in people with HIV Lipodystrophy, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Body composition (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2016.