HIVNCT01579695
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
An observational study of HIV, run by Theratechnologies at 31 sites in United States.
Trial summary
The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Tesamorelin for injection
- Type of treatment
- Injection or infusion
- How many people
- 391 participants
- Where
- 31 sitesUnited States
- Study dates
- Feb 2013to Aug 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy
Who may be able to join
- All of the following inclusion criteria must be fulfilled:
- Subject has given written informed consent;
- Subject is an adult man or woman ≥ 18 years old;
- Subject has HIV infection;
- Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
- Subject has completed standard of care assessments (mammography, cervical PAP smear, colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study.
Who cannot join
- Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.
- Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
- Active malignancy (newly diagnosed or recurrent)
- Known hypersensitivity to tesamorelin and/or mannitol
- Pregnancy or lactation
- Use of EGRIFTA® within 6 months prior to baseline
- Failure to complete any standard of care assessments listed in Section 5.2.1
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Summa Health Care System
Akron, Ohio, 44304
Absolute Care Medical Center
Atlanta, Georgia, 30309
Franco Felizarta, MD
Bakersfield, California, 93301
St. Hope Foundation, Inc.
Bellaire, Texas, 77401
Be Well Medical Center, P.C
Berkley, Michigan, 48072-3436
Massachusetts General Hospital
Boston, Massachusetts, 02114
University at Buffalo, State University of NY, Erie County Medical Center
Buffalo, New York, 14215
Northstar Medical Center
Chicago, Illinois, 60657
Dallas VA Medical Center
Dallas, Texas, 75216
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Gary J. Richmond, M.D., PA
Fort Lauderdale, Florida, 33316
Pacific Coast Medical Group
Fountain Valley, California, 92708
University of California CARE Clinic, Los Angeles
Los Angeles, California, 90035
Tower Infectious Diseases Medical Associates
Los Angeles, California, 90048
Oasis Clinic
Los Angeles, California, 90095
The Kinder Medical Group-AHF
Miami, Florida, 33133
Ricky K. Hsu, MD, PC
New York, New York, 10011
Orange County Health Department
Orlando, Florida, 32805
Orange County Health Department
Orlando, Florida, 32809
VAMC, Infectious Disease Section 111W
San Francisco, California, 94121
Virginia Mason Medical Center
Seattle, Washington, 98112
South Jersey Unfectious Disease
Somers Point, New Jersey, 08244
Southern Illnois University School of Medicine
Springfield, Illinois, 62702
The Researth Institute
Springfield, Massachusetts, 01105
Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
St Louis, Missouri, 63108
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
Virginia Mason Medical Center
Tulsa, Oklahoma, 74127
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
Rowan Tree Medical, P.A.
Wilton Manors, Florida, 33305
About this study
Official title: A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
- Conditions
- HIV
- Being tested
- Tesamorelin for injection
- Keywords
- HIV with lipohypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesamorelin for injectionDrug
Daily 2 mg subcutaneous injections of Tesamorelin
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group will receive Tesamorelin | Not described Receives: Drug: Tesamorelin for injection | |
| Control Group will not receive Tesamorelin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
Measured: 10 years
Secondary outcomes (1)
Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theratechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Mamputu, PhD, Theratechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579695
- Sponsor's protocol ID
- EMR200147-501
- Status last verified
- Sep 2018
- First submitted
- 12 Apr 2012
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
- ClinicalTrials.gov ID
- NCT01579695
- Acronym / sponsor ID
- EMR200147-501
- Conditions
- HIV
- Keywords
- HIV with lipohypertrophy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 391 participants (actual)
- Lead sponsor
- TheratechnologiesIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Apr 2012 (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.
The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group will receive Tesamorelin | – | Drug: Tesamorelin for injection |
| Control Group will not receive Tesamorelin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy
Key inclusion criteria (6 listed)
- Subject has given written informed consent;
- Subject is an adult man or woman ≥ 18 years old;
- Subject has HIV infection;
- Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
- Subject has completed standard of care assessments (mammography, cervical PAP smear, colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study.
Key exclusion criteria (7 listed)
- Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.
- Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
- Active malignancy (newly diagnosed or recurrent)
- Known hypersensitivity to tesamorelin and/or mannitol
- Pregnancy or lactation
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 |
|---|---|---|
| Tesamorelin for injectionDaily 2 mg subcutaneous injections of Tesamorelin | Drug | Exposed Group will receive Tesamorelin |
Primary outcome
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
Time frame: 10 years
1 secondary outcome
Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events
Time frame: 10 years
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 11 Sep 2018.
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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.
Jean-Claude Mamputu, PhD
Theratechnologies Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Theratechnologies at 31 sites 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 6 inclusion and 7 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA® (time frame: 10 years). 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 11 Sep 2018.