Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Theratechnologies
Sponsor:
Information provided by (Responsible Party):
Theratechnologies
ClinicalTrials.gov Identifier:
NCT01591902
First received: May 2, 2012
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
Diabetic Retinopathy
HIV
Drug: Tesamorelin
Drug: Placebo-Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate Whether EGRIFTA® (Tesamorelin for Injection), 2 mg Once Daily SC, Increases the Risk of Development or Progression of Diabetic Retinopathy When Administered to HIV-infected Subjects With Abdominal Lipohypertrophy and Concomitant Diabetes

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months


Secondary Outcome Measures:
  • Change from baseline in HbA1c by intensification of concomitant diabetic treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    HbA1c values will be obtained at screening at month 3, 6, 12, 18, 24, 30 and 36


Estimated Enrollment: 648
Study Start Date: June 2012
Estimated Study Completion Date: September 2024
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGRIFTA Treatment Grop
Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient
Drug: Tesamorelin
Daily 2 mg subcutaneous injections of tesamorelin
Placebo Comparator: Placebo
Placebo-controlled
Drug: Placebo-Control
3.0 mL vials

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Subject has given written informed consent and is willing to comply with the requirements of the protocol;
  2. Subject is an adult man or woman (≥ 18 years old);
  3. Subject has laboratory confirmed HIV infection;
  4. Subject is receiving ART that has been stable for at least 8 weeks prior to screening;
  5. Subject has physical evidence of abdominal lipohypertrophy, as determined by the examining study physician;
  6. Subject has T2DM as determined by previous HbA1c ≥ 6.5%, previous fasting plasma glucose

    • ≥ 126 mg/dL (7.0 mmol/L), and/or previous 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during oral glucose tolerance testing (OGTT), and/or previous random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) with symptoms of uncontrolled DM;
    • if subject has been diagnosed with T2DM and is on glucose lowering medications for greater than 1 year the above glucose parameters do not apply;
  7. Subject, at the time of screening, has HbA1c between 6.0% and 12.0%;
  8. Subject's diabetes has been treated for at least 1 year by diet alone, individuals who are on a stable dose (at least 3 months) of insulin, an OHA, or a GLP-1 analogue plus insulin to control diabetes are permitted if their HbA1C is below 6.0%. OHA, GLP-1 analogue, or OHA/GLP-1 analogue plus insulin according to current American Diabetes Association (ADA) guidelines, and doses have been stable for at least 3 months;
  9. If the subject is using lipid lowering drugs, the dose must be stable for at least 2 months prior to screening;
  10. Subject must have an electrocardiogram (ECG) without clinically significant abnormalities within 6 months prior to screening;
  11. Pre-menopausal women of childbearing potential are eligible only if they are not pregnant (negative urine pregnancy tests at screening and baseline) or lactating and are using an acceptable form of birth control prior to study entry and for at least 2 months after completing treatment. Acceptable contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device, or an oral contraceptive;
  12. Women of non-childbearing potential must be post-menopausal (no menses for more than 1 year) or surgically sterile (tubal ligation or hysterectomy);
  13. Women over 40 years old must have a negative mammogram within 6 months prior to screening or a mammogram will be taken at screening;
  14. Men must have a normal prostate exam and a prostate specific antigen (PSA) Individuals who are on a stable dose (at least 3 months) of insulin, less than or equal to 5 ng/mL within 6 months prior to screening or PSA and, for men 50 years of age or older, a prostate specific antigen will be measured at screening

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591902

Contacts
Contact: Theratechnologies Medical Information 514-336-7800

Locations
United States, Arizona
Southwest Center for HIV/AIDS Recruiting
Phoenix, Arizona, United States, 85004
Contact: Joyce Nelson    602-595-8169      
Principal Investigator: Timothy Kuberski, MD         
Spectrum Medical Group Recruiting
Phoenix, Arizona, United States, 85012
Contact: Gilda De La Garza    602-604-9500      
Principal Investigator: Thanes Vanig, M.D.         
United States, California
5P21 Rand Schrader Clinic Recruiting
Los Angeles, California, United States, 90033
Contact: Frances Canchola    323-343-8281      
Principal Investigator: Michael Dube, M.D.         
University of California CARE Clinic, Los Angeles Recruiting
Los Angeles, California, United States, 90035
Contact: Vanessa Cajahuaringa    310-557-9640      
Principal Investigator: Jordan Lake, M.D.         
Palmtree Clinical Research, Inc. Recruiting
Palm Springs, California, United States, 92262
Contact: Erik Hernandez    760-902-9615      
Principal Investigator: Richard Loftus, M.D.         
UCSD Antiviral Research Center Recruiting
San Diego, California, United States, 92103
Contact: Linda Meixner    619-543-8241      
Principal Investigator: Daniel Lee, M.D.         
VAMC, Infectious Disease Section 111W Recruiting
San Francisco, California, United States, 94121
Contact: Heather Freasier    415-379-5518      
Principal Investigator: Phyllis Tien, M.D.         
United States, District of Columbia
Capital Medical Associates, PC Recruiting
Washington, District of Columbia, United States, 20036
Contact: Kenneth Granville    202-822-6311      
Principal Investigator: Theo Hodge, Jr., M.D.         
United States, Florida
Gary J. Richmond, M.D., PA Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Vernon Appleby    954-524-2250 ext 211      
Principal Investigator: Gary J. Richmond, M.D.         
Orange County Health Department Recruiting
Orlando, Florida, United States, 32809
Contact: Willie Carter    407-858-1436      
Principal Investigator: Ewa Szczypinska, MD         
Triple O Research Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Jenn Kuretski    561-832-6770      
Principal Investigator: Olayemi Osiyemi, M.D.         
Rowan Tree Medical , P.A. Recruiting
Wilton Manors, Florida, United States, 33305
Contact: Avery Woodard    954-533-5382      
Principal Investigator: Jennifer Bartczak, M.D.         
United States, Michigan
Be Well Medical Center, P.C. Recruiting
Berkley, Michigan, United States, 48072-3436
Contact: Crystal Khan    248-544-9300      
Principal Investigator: Paul Benson, D.O.         
United States, Missouri
Southampton Clinical Research, Inc d.b.a. Central West Clinical Research Recruiting
St. Louis, Missouri, United States, 63108
Contact: Mustafa Allami    314-652-0100 ext 829      
Principal Investigator: David Parks, M.D.         
Southampton Healthcare, Inc. Recruiting
St. Louis, Missouri, United States, 63139
Contact: Dan Swiercz    314-647-2200 ext 103      
Principal Investigator: David Prelutsky, M.D.         
United States, New Jersey
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
Contact: Kelly Freeman    609-927-6662 ext 5      
Principal Investigator: Christopher Lucasti, D.O., FACOI         
United States, Oklahoma
Harold Hamm Diabetes Center at the University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Jennifer Salazar    405-271-4655      
Principal Investigator: James Lane, MD         
United States, Oregon
Fanno Creek Clinic, LLC Recruiting
Portland, Oregon, United States, 97219
Contact: Lisa Zeigler    503-452-0915 ext 130      
Principal Investigator: Gregg Coodley, M.D., FACP         
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
Contact: Ronnie Milam    512-480-9660      
Principal Investigator: Cynthis Brinson, M.D.         
St. Hope Foundation, Inc. Recruiting
Bellaire, Texas, United States, 77401
Contact: Saima Azeem    713-844-8035      
Principal Investigator: James Sims, MD         
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Joyce Ghormley    214-857-1606      
Principal Investigator: Roger Bedimo, M.S., M.D.         
UT Southwestern Medical Center, Atten: HIV Research Unit Recruiting
Dallas, Texas, United States, 75235
Contact: Minerva Santos    214-590-2794      
Principal Investigator: Mamta Jain, M.D.         
Research Access Network Recruiting
Houston, Texas, United States, 77098
Contact: A.J. Sarabia    713-526-7732      
Principal Investigator: Shannon R. Schrader, M.D.         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98112
Contact: Leila Ponce    206-625-7373      
Principal Investigator: David Aboulafia, M.D.         
Sponsors and Collaborators
Theratechnologies
Investigators
OverallOfficial: Jean-Claude Mamputu, PhD Theratechnologies Inc.
  More Information

Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT01591902     History of Changes
Other Study ID Numbers: EMR200147-500 
Study First Received: May 2, 2012
Last Updated: August 12, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Angiopathies
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 30, 2016