Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT01579695
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01579695
Study Brief:
Protocol Section:
NCT01579695