Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

Phase 4

Terminated

• Conditions: Diabetic Retinopathy; HIV
• Interventions: Drug: Placebo-Control; Drug: Tesamorelin

• Registration Number: NCT01591902
• Lead Sponsor: Theratechnologies

Brief Summary

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).

Detailed Description

To date, EGRIFTA® has not been studied for longer than 1 year in human subjects, nor has EGRIFTA® been studied in Type 2 diabetic HIV-infected subjects who are receiving oral hypoglycemic agents, GLP-1 analogues, or insulin. The present study will assess the potential of EGRIFTA® to induce or exacerbate DR in HIV-infected subjects on antiretroviral therapy who have concomitant abdominal lipohypertrophy and T2DM, and explore the long-term effects of EGRIFTA® on glycemic control and major adverse cardiovascular event (MACE) in this population.

Study Timeline

• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Study Start: 2012-06
• 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: 129

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Subject has Type 1 DM;

2. Subject has body mass index (BMI) < 18.5 kg.m2;

3. Subject has or has had an opportunistic infection or acquired immune deficiency syndrome (AIDS)-defining illness within 3 months of screening;

4. Subject has or has had a malignancy or, for women, personal or family (first degree relative) history of breast cancer. Exceptions are basal cell carcinoma, in situ carcinoma of the cervix, in situ anal carcinoma, treated and stable cutaneous squamous cell carcinoma. and stable Kaposi's sarcoma;

5. Pre-existing PDR or severe non-PDR (NPDR), defined as an ETDRS level of ≥ 53 in either eye;

6. Subject has or has had cytomegalovirus (CMV) retinitis, toxoplasmosis, or any other ocular infection that would prevent evaluation of DR;

7. Subject has previously been treated for DR (treatments such as laser photocoagulation, intravitreal injection, or vitrectomy);

8. Subject has any of the following illnesses or conditions:

   1. hypopituitarism, history of pituitary tumor or pituitary surgery;
   2. untreated hypothyroidism;
   3. head irradiation or head trauma that has affected the somatotropic axis;
   4. uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg;
   5. unstable CV condition, defined as:

   i. acute MI; ii. unstable angina; iii. decompensated congestive heart failure (CHF, new onset or exacerbation); iv. stroke; v. history of any of the above within 6 months prior to screening; f. hepatic abnormality, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (3 x ULN); g. renal abnormality, defined as serum creatinine > 2 x ULN; h. lipid metabolism abnormality, defined as fasting triglycerides > 1500 mg/dL; i. anemia, defined as hemoglobin ≤ 7 g/dL;

9. Drug or hormone use as follows

   1. Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening;
   2. anabolic steroids, GH, GH secretagogue, GHRF products or analogs (including EGRIFTA®), IGF-1, or IGF binding protein 3 (IGFBP 3) within 6 months prior to screening;

10. Drug or alcohol dependence within 6 months prior to screening;

11. Subject is using or has used anorectics, anorexigenics, or anti-obesity agents within 3 months prior to screening;

12. Subject is pregnant or nursing;

13. Other significant disease that, in the Investigator's opinion, would exclude the subject from the trial;

14. Participation, within 30 days prior to screening, in another clinical trial of an investigational agent that could affect IGF-1 levels;

15. Known hypersensitivity to the study drug treatments.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo-Control	Placebo-controlled
EGRIFTA Treatment Grop	Tesamorelin	Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient

Primary Outcome Measures

Name	Time	Method
Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.	3 years	Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c by intensification of concomitant diabetic treatment	3 years	HbA1c values will be obtained at screening at month 3, 6, 12, 18, 24, 30 and 36

Trial Locations

Locations (24)

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

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

5P21 Rand Schrader Clinic; 🇺🇸 Los Angeles, California, United States

Southampton Clinical Research, Inc d.b.a. Central West Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Spectrum Medical Group; 🇺🇸 Phoenix, Arizona, United States

UCSD Antiviral Research Center; 🇺🇸 San Diego, California, United States

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

Harold Hamm Diabetes Center at the University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Palmtree Clinical Research, Inc.; 🇺🇸 Palm Springs, California, United States

Research Access Network; 🇺🇸 Houston, Texas, United States

Rowan Tree Medical , P.A.; 🇺🇸 Wilton Manors, Florida, United States

Southwest Center for HIV/AIDS; 🇺🇸 Phoenix, Arizona, United States

Orange County Health Department; 🇺🇸 Orlando, Florida, United States

Southampton Healthcare, Inc.; 🇺🇸 Saint Louis, Missouri, United States

Triple O Research Institute; 🇺🇸 West Palm Beach, Florida, United States

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

South Jersey Infectious Disease; 🇺🇸 Somers Point, New Jersey, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States

St. Hope Foundation, Inc.; 🇺🇸 Bellaire, Texas, United States

Be Well Medical Center, P.C.; 🇺🇸 Berkley, Michigan, United States

UT Southwestern Medical Center, Atten: HIV Research Unit; 🇺🇸 Dallas, Texas, United States

Fanno Creek Clinic, LLC; 🇺🇸 Portland, Oregon, United States