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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Theratechnologies
Sponsor:
Information provided by (Responsible Party):
Theratechnologies
ClinicalTrials.gov Identifier:
NCT01579695
First received: April 12, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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®.


Condition Intervention
HIV
Drug: Tesamorelin for injection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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®

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3190
Study Start Date: February 2013
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed Group will receive Tesamorelin Drug: Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Control Group will not receive Tesamorelin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579695

Contacts
Contact: Theratechnologies Medical Information 1-844-347-4382

  Show 44 Study Locations
Sponsors and Collaborators
Theratechnologies
Investigators
Investigator: Monika Zoltowska, PhD Theratechnologies Inc.
  More Information

No publications provided

Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT01579695     History of Changes
Other Study ID Numbers: EMR200147-501
Study First Received: April 12, 2012
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theratechnologies:
HIV with lipohypertrophy

Additional relevant MeSH terms:
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014