Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®

September 10, 2018 updated by: Theratechnologies

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®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
391

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Franco Felizarta, MD
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Medical Group
      • Los Angeles, California, United States, 90048
        • Tower Infectious Diseases Medical Associates
      • Los Angeles, California, United States, 90035
        • University of California CARE Clinic, Los Angeles
      • Los Angeles, California, United States, 90095
        • OASIS Clinic
      • San Francisco, California, United States, 94121
        • VAMC, Infectious Disease Section 111W
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physician's Group
      • Washington, District of Columbia, United States, 20036
        • Capital Medical Associates, PC
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary J. Richmond, M.D., PA
      • Miami, Florida, United States, 33133
        • The Kinder Medical Group-AHF
      • Orlando, Florida, United States, 32809
        • Orange County Health Department
      • Orlando, Florida, United States, 32805
        • Orange County Health Department
      • Wilton Manors, Florida, United States, 33305
        • Rowan Tree Medical, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Absolute Care Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illnois University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Springfield, Massachusetts, United States, 01105
        • The Researth Institute
    • Michigan
      • Berkley, Michigan, United States, 48072-3436
        • Be Well Medical Center, P.C
    • Missouri
      • Saint Louis, Missouri, United States, 63139
        • Southampton Healthcare, Inc.
      • Saint Louis, Missouri, United States, 63108
        • Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Unfectious Disease
    • New York
      • Buffalo, New York, United States, 14215
        • University at Buffalo, State University of NY, Erie County Medical Center
      • New York, New York, United States, 10011
        • Ricky K. Hsu, MD, PC
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health Care System
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74127
        • Virginia Mason Medical Center
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital and Medical Center
    • Texas
      • Bellaire, Texas, United States, 77401
        • St. Hope Foundation, Inc.
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center at Dallas
    • Washington
      • Seattle, Washington, United States, 98112
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy

Description

Inclusion Criteria:

All of the following inclusion criteria must be fulfilled:

  1. Subject has given written informed consent;
  2. Subject is an adult man or woman ≥ 18 years old;
  3. Subject has HIV infection;
  4. Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
  5. 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.

Exclusion Criteria:

Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.

  1. Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
  2. Active malignancy (newly diagnosed or recurrent)
  3. Known hypersensitivity to tesamorelin and/or mannitol
  4. Pregnancy or lactation
  5. Use of EGRIFTA® within 6 months prior to baseline
  6. Failure to complete any standard of care assessments listed in Section 5.2.1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Exposed Group will receive Tesamorelin
Drug: Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Control Group will not receive Tesamorelin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theratechnologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Jean-Claude Mamputu, PhD, Theratechnologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMR200147-501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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