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

This study is currently recruiting participants.
Verified January 2014 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01579695
First received: April 12, 2012
Last updated: January 15, 2014
Last verified: January 2014

April 12, 2012
January 15, 2014
February 2013
December 2024   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01579695 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
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®.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

HIV
Drug: Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
  • Exposed Group will receive Tesamorelin
    Intervention: Drug: Tesamorelin for injection
  • Control Group will not receive Tesamorelin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3190
January 2025
December 2024   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: EMD Serono Medical Information 888-275-7376
United States
 
NCT01579695
EMR200147-501
Yes
EMD Serono
EMD Serono
Not Provided
Study Director: Daniela Rogoff, MD, MPH EMD Serono, Inc.
EMD Serono
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP