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Diabetic RetinopathyPhase 4NCT01591902

Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

A Phase 4 study testing Tesamorelin in people with Diabetic Retinopathy and HIV, run by Theratechnologies at 24 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy, HIV
What is being tested?
Tesamorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
24 sitesUnited States
Study dates
Jun 2012to Aug 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has given written informed consent and is willing to comply with the requirements of the protocol;
  • Subject is an adult man or woman (≥ 18 years old);
  • Subject has laboratory confirmed HIV infection;
  • Subject is receiving ART that has been stable for at least 8 weeks prior to screening;
  • Subject has physical evidence of abdominal lipohypertrophy, as determined by the examining study physician;
  • Subject has T2DM as determined by previous HbA1c ≥ 6.5%, previous fasting plasma glucose
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  • ≥ 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;
  • Subject, at the time of screening, has HbA1c between 6.0% and 12.0%;
  • 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;
  • If the subject is using lipid lowering drugs, the dose must be stable for at least 2 months prior to screening;
  • Subject must have an electrocardiogram (ECG) without clinically significant abnormalities within 6 months prior to screening;
  • 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;
  • Women of non-childbearing potential must be post-menopausal (no menses for more than 1 year) or surgically sterile (tubal ligation or hysterectomy);
  • Women over 40 years old must have a negative mammogram within 6 months prior to screening or a mammogram will be taken at screening;
  • 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

Who cannot join

  • Subject has Type 1 DM;
  • Subject has body mass index (BMI) < 18.5 kg.m2;
  • Subject has or has had an opportunistic infection or acquired immune deficiency syndrome (AIDS)-defining illness within 3 months of screening;
  • 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;
  • Pre-existing PDR or severe non-PDR (NPDR), defined as an ETDRS level of ≥ 53 in either eye;
  • Subject has or has had cytomegalovirus (CMV) retinitis, toxoplasmosis, or any other ocular infection that would prevent evaluation of DR;
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  • Subject has previously been treated for DR (treatments such as laser photocoagulation, intravitreal injection, or vitrectomy);
  • Subject has any of the following illnesses or conditions:
  • hypopituitarism, history of pituitary tumor or pituitary surgery;
  • untreated hypothyroidism;
  • head irradiation or head trauma that has affected the somatotropic axis;
  • uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg;
  • unstable CV condition, defined as:
  • 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;
  • Drug or hormone use as follows
  • Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening;
  • 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;
  • Drug or alcohol dependence within 6 months prior to screening;
  • Subject is using or has used anorectics, anorexigenics, or anti-obesity agents within 3 months prior to screening;
  • Subject is pregnant or nursing;
  • Other significant disease that, in the Investigator's opinion, would exclude the subject from the trial;
  • Participation, within 30 days prior to screening, in another clinical trial of an investigational agent that could affect IGF-1 levels;
  • Known hypersensitivity to the study drug treatments.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • St. Hope Foundation, Inc.

    Bellaire, Texas, 77401

  • Be Well Medical Center, P.C.

    Berkley, Michigan, 48072-3436

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • UT Southwestern Medical Center, Atten: HIV Research Unit

    Dallas, Texas, 75235

  • Gary J. Richmond, M.D., PA

    Fort Lauderdale, Florida, 33316

  • Research Access Network

    Houston, Texas, 77098

  • 5P21 Rand Schrader Clinic

    Los Angeles, California, 90033

  • University of California CARE Clinic, Los Angeles

    Los Angeles, California, 90035

  • Harold Hamm Diabetes Center at the University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Orange County Health Department

    Orlando, Florida, 32809

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona, 85004

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Fanno Creek Clinic, LLC

    Portland, Oregon, 97219

  • UCSD Antiviral Research Center

    San Diego, California, 92103

  • VAMC, Infectious Disease Section 111W

    San Francisco, California, 94121

  • Virginia Mason Medical Center

    Seattle, Washington, 98112

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Southampton Clinical Research, Inc d.b.a. Central West Clinical Research

    St Louis, Missouri, 63108

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • Triple O Research Institute

    West Palm Beach, Florida, 33401

  • Rowan Tree Medical , P.A.

    Wilton Manors, Florida, 33305

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Tesamorelin, Placebo-Control
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TesamorelinDrug

    Daily 2 mg subcutaneous injections of tesamorelin

  • Placebo-ControlDrug

    3.0 mL vials

Study groups in NCT01591902
Study groupRoleWhat they receive
EGRIFTA Treatment GropExperimentalSterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient
Receives: Drug: Tesamorelin
PlaceboPlacebo comparatorPlacebo-controlled
Receives: Drug: Placebo-Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months

    Measured: 3 years

Secondary outcomes (1)

  1. Change from baseline in HbA1c by intensification of concomitant diabetic treatment

    HbA1c values will be obtained at screening at month 3, 6, 12, 18, 24, 30 and 36

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionMay 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01591902
Sponsor's protocol ID
EMR200147-500
Status last verified
Sep 2018
First submitted
2 May 2012
Last updated
11 Sep 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tesamorelin in people with Diabetic Retinopathy and HIV, run by Theratechnologies at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01591902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.

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