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

Terminated

• Conditions: HIV
• Interventions: Drug: Tesamorelin for injection

• Registration Number: NCT01579695
• Lead Sponsor: Theratechnologies

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Study Start: 2013-02
• Primary Completion: 2018-05
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 391

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed Group will receive Tesamorelin	Tesamorelin for injection	-

Primary Outcome Measures

Name	Time	Method
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®	10 years

Secondary Outcome Measures

Name	Time	Method
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	10 years

Trial Locations

Locations (29)

Franco Felizarta, MD; 🇺🇸 Bakersfield, California, United States

Pacific Coast Medical Group; 🇺🇸 Fountain Valley, California, United States

University of California CARE Clinic, Los Angeles; 🇺🇸 Los Angeles, California, United States

Tower Infectious Diseases Medical Associates; 🇺🇸 Los Angeles, California, United States

Oasis Clinic; 🇺🇸 Los Angeles, California, United States

VAMC, Infectious Disease Section 111W; 🇺🇸 San Francisco, California, United States

Dupont Circle Physician's Group; 🇺🇸 Washington, District of Columbia, United States

Capital Medical Associates, PC; 🇺🇸 Washington, District of Columbia, United States

Gary J. Richmond, M.D., PA; 🇺🇸 Fort Lauderdale, Florida, United States

The Kinder Medical Group-AHF; 🇺🇸 Miami, Florida, United States

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