EMR200147-501: 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
This study is a multicenter, observational, 2-arm parallel prospective group study without treatment assignment. Subjects will undergo baseline assessments prior to the beginning of the 10-year observation period. The decision
of whether to begin eGRiFTa[RegisteredTM] treatment will be made by the physician and subject; the Sponsor will have no input
into this decision.
During the 10-year observation period, laboratory and safety assessments will be made at 6- or 12-month
intervals ((+-) 3-month window), depending on the parameter. at the conclusion of the 10-year observation period, the
subject will be asked to complete a final assessment visit.
The time to development of malignancy in HiV-infected subjects with abdominal lipohypertrophy exposed to eGRiFTa[RegisteredTM] (Group 1) compared with a concurrent, comparable control group not exposed to eGRiFTa[RegisteredTM] (Group 2)
1. The comparison of the development or worsening of T2DM and related conditions, including worsening of glucose tolerance, between Group 1 and Group 2, as follows:
a. the time to worsening glucose tolerance, defined as development or worsening of T2DM or pre-T2DM using the aDa definition based on fasting blood glucose (FBG) or Hba1c levels or initiation of diabetic treatment, will be evaluated for the subset of subjects with normal glucose or Hba1c levels at baseline;
b. the time to development or worsening of DR will be evaluated for the subset of subjects with T2DM at baseline or who developed T2DM during the study;
c. the time to worsening of T2DM, as determined by the treating physician, based on changes in the diabetic treatment regimen and/or Hba1c levels, will be evaluated for the subset of subjects with T2DM at baseline or who developed T2DM during the study.
2. The time to development of hypersensitivity reactions in Group 1 compared with Group 2.
3. The time to onset of aes associated with hepatic and renal function in Group 1 compared with Group 2.
4. The time to onset of MaCe in Group 1 compared with Group 2.
MaCe is defined as any of the following: fatal or nonfatal Mi, fatal or nonfatal stroke, unstable angina, coronary revascularization procedure (i.e., percutaneous coronary angioplasty with or without stent placement, coronary artery bypass surgery), or peripheral vascular disease (PVD; i.e., severe claudication, evidence of PVD by ankle brachial index [aBi], or lower extremity revascularization procedure).
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, lipid panel ) prior to being enrolled onto the study.