Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
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ClinicalTrials.gov Identifier: NCT01579695 |
Recruitment Status
:
Recruiting
First Posted
: April 18, 2012
Last Update Posted
: August 15, 2016
|
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Condition or disease | Intervention/treatment |
---|---|
HIV | Drug: Tesamorelin for injection |
Study Type : | Observational |
Estimated Enrollment : | 3190 participants |
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® |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | December 2029 |
Estimated Study Completion Date : | March 2030 |

Group/Cohort | Intervention/treatment |
---|---|
Exposed Group will receive Tesamorelin |
Drug: Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
|
Control Group will not receive Tesamorelin |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
All of the following inclusion criteria must be fulfilled:
- Subject has given written informed consent;
- Subject is an adult man or woman ≥ 18 years old;
- Subject has HIV infection;
- Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
- 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®.
- Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
- Active malignancy (newly diagnosed or recurrent)
- Known hypersensitivity to tesamorelin and/or mannitol
- Pregnancy or lactation
- Use of EGRIFTA® within 6 months prior to baseline
- Failure to complete any standard of care assessments listed in Section 5.2.1

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579695
Contact: Theratechnologies Medical Information | 1-844-347-4382 |

OverallOfficial: | Jean-Claude Mamputu, PhD | Theratechnologies Inc. |
Responsible Party: | Theratechnologies |
ClinicalTrials.gov Identifier: | NCT01579695 History of Changes |
Other Study ID Numbers: |
EMR200147-501 |
First Posted: | April 18, 2012 Key Record Dates |
Last Update Posted: | August 15, 2016 |
Last Verified: | August 2016 |
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 |