Clinical Trial Details

NCT ID: NCT01591902
Date Last Changed: August 11, 2015

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetic Retinopathy or HIV

Research Study 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

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).

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Recruitment Details

Phase
4
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Theratechnologies
Duration
48 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

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

  7. ≥ 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;

  8. 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;

  9. Subject, at the time of screening, has HbA1c between 6.0% and 12.0%;

  10. 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;

  11. If the subject is using lipid lowering drugs, the dose must be stable for at least 2 months prior to screening;

  12. Subject must have an electrocardiogram (ECG) without clinically significant abnormalities within 6 months prior to screening;

  13. 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;

  14. Women of non-childbearing potential must be post-menopausal (no menses for more than 1 year) or surgically sterile (tubal ligation or hysterectomy);

  15. Women over 40 years old must have a negative mammogram within 6 months prior to screening or a mammogram will be taken at screening;

  16. 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:

  9. hypopituitarism, history of pituitary tumor or pituitary surgery;

  10. untreated hypothyroidism;

  11. head irradiation or head trauma that has affected the somatotropic axis;

  12. uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg;

  13. 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;

  1. Drug or hormone use as follows

  2. Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening;

  3. 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;

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

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

  6. Subject is pregnant or nursing;

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

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

  9. Known hypersensitivity to the study drug treatments.

Site Locations (26)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85012 Spectrum Medical Group
Gilda De La Garza
602-604-9500

Thanes Vanig, M.D.
Principal Investigator
United States California Fountain Valley 92708 Pacific Coast Medical Group
Dean Bosman
714-698-0300 ext. 220

Sujata Lalla-Reddy, M.D.
Principal Investigator
United States California Los Angeles 90033 5P21 Rand Schrader Clinic
Frances Canchola
323-343-8281

Michael Dube, M.D.
Principal Investigator
United States California Los Angeles 90035 University of California CARE Clinic, Los Angeles
Vanessa Cajahuaringa
310-557-9640

Jordan Lake, M.D.
Principal Investigator
United States California Palm Springs 92262 Palmtree Clinical Research, Inc.
Erik Hernandez
760-902-9615

Richard Loftus, M.D.
Principal Investigator
United States California San Diego 92103 UCSD Antiviral Research Center
Linda Meixner
619-543-8241

Daniel Lee, M.D.
Principal Investigator
United States California San Francisco 94121 VAMC, Infectious Disease Section 111W
Heather Freasier
415-379-5518

Phyllis Tien, M.D.
Principal Investigator
United States Connecticut Norwich 06360 The William W. Backus Hospital
Paula Provost
860-892-6936

Clifford Stirba, M.D.
Principal Investigator
United States District of Columbia Washington 20036 Capital Medical Associates, PC
Kenneth Granville
202-822-6311

Theo Hodge, Jr., M.D.
Principal Investigator
United States Florida Fort Lauderdale 33316 Gary J. Richmond, M.D., PA
Vernon Appleby
954-524-2250 ext. 211

Gary J. Richmond, M.D.
Principal Investigator
United States Florida Miami 33133 The Kinder Medical Group-AHF
Michele Manrique
786-497-4000 ext. 232

Clifford A. Kinder, M.D.
Principal Investigator
United States Florida West Palm Beach 33401 Triple O Research Institute
Jenn Kuretski
561-832-6770

Olayemi Osiyemi, M.D.
Principal Investigator
United States Florida Wilton Manors 33305 Rowan Tree Medical , P.A.
Avery Woodard
954-533-5382

Jennifer Bartczak, M.D.
Principal Investigator
United States Illinois Springfield 62702 Southern Illinois University School of Medicine
Jennifer Andoh
217-545-9491

Janak Koirala, M.D.
Principal Investigator
United States Iowa Iowa City 52242 University of Iowa
Pam Terrill
319-384-8727

Jeffrey Meier, M.D.
Principal Investigator
United States Michigan Berkley 48072-3436 Be Well Medical Center, P.C.
Crystal Khan
248-544-9300

Paul Benson, D.O.
Principal Investigator
United States Missouri St. Louis 63108 Southampton Clinical Research, Inc d.b.a. Central West Clinical Research
Mustafa Allami
314-652-0100 ext. 829

David Parks, M.D.
Principal Investigator
United States Missouri St. Louis 63139 Southampton Healthcare, Inc.
Dan Swiercz
314-647-2200 ext. 103

David Prelutsky, M.D.
Principal Investigator
United States New Jersey Somers Point 08244 South Jersey Infectious Disease
Kelly Freeman
609-927-6662 ext. 5

Christopher Lucasti, D.O., FACOI
Principal Investigator
United States Oregon Portland 97219 Fanno Creek Clinic, LLC
Lisa Zeigler
503-452-0915 ext. 130

Gregg Coodley, M.D., FACP
Principal Investigator
United States Pennsylvania West Reading 19611 Reading Hospital and Medical Center
Julie Sheidy
484-628-4317

Robert Jones, D.O.
Principal Investigator
United States Texas Austin 78705 Central Texas Clinical Research
Ronnie Milam
512-480-9660

Cynthis Brinson, M.D.
Principal Investigator
United States Texas Dallas 75216 Dallas VA Medical Center
Joyce Ghormley
214-857-1606

Roger Bedimo, M.S., M.D.
Principal Investigator
United States Texas Dallas 75235 UT Southwestern Medical Center, Atten: HIV Research Unit
Minerva Santos
214-590-2794

Mamta Jain, M.D.
Principal Investigator
United States Texas Houston 77098 Research Access Network
A.J. Sarabia
713-526-7732

Shannon R. Schrader, M.D.
Principal Investigator
United States Washington Seattle 98112 Virginia Mason Medical Center
Leila Ponce
206-625-7373

David Aboulafia, M.D.
Principal Investigator

Contact

Theratechnologies Medical Information
514-336-7800

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