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

This study is currently recruiting participants.
Verified February 2013 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01579695
First received: April 12, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tesamorelin
U.S. FDA Resources

Further study details as provided by EMD Serono:

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.

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

Contacts
Contact: EMD Serono Medical Information 888-275-7376

Locations
United States, Massachusetts
Call EMD Serono Medical Information for information on recruiting sites Recruiting
Rockland, Massachusetts, United States, 02370
Call EMD Serono Medical Information for Recruiting Sites Recruiting
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Alexandra Mangili, MD, MPH EMD Serono, Inc.
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01579695     History of Changes
Other Study ID Numbers: EMR200147-501
Study First Received: April 12, 2012
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
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 March 07, 2013