Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

NCT01591902 | Terminated Phase 4 DMC

• 1 other identifier: EMR200147-500
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 24

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).

Conditions

Diabetic Retinopathy; HIV

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (1)

• Change from baseline in HbA1c by intensification of concomitant diabetic treatment

  3 years

Study Arms (2)

EGRIFTA Treatment Grop

EXPERIMENTAL

Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient

Drug: Tesamorelin

Placebo

PLACEBO COMPARATOR

Placebo-controlled

Drug: Placebo-Control

Interventions

Tesamorelin DRUG

Daily 2 mg subcutaneous injections of tesamorelin

EGRIFTA Treatment Grop

Placebo-Control DRUG

3.0 mL vials

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥ 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;

You may not qualify if:

• 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;
• 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:
• 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;
• Drug or hormone use as follows

Sponsors & Collaborators

• Theratechnologies: lead

Study Sites (24)

Southwest Center for HIV/AIDS

Phoenix, Arizona, 85004, United States

Location

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

5P21 Rand Schrader Clinic

Los Angeles, California, 90033, United States

Location

University of California CARE Clinic, Los Angeles

Los Angeles, California, 90035, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

Location

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

VAMC, Infectious Disease Section 111W

San Francisco, California, 94121, United States

Location

Capital Medical Associates, PC

Washington D.C., District of Columbia, 20036, United States

Location

Gary J. Richmond, M.D., PA

Fort Lauderdale, Florida, 33316, United States

Location

Orange County Health Department

Orlando, Florida, 32809, United States

Location

Triple O Research Institute

West Palm Beach, Florida, 33401, United States

Location

Rowan Tree Medical , P.A.

Wilton Manors, Florida, 33305, United States

Location

Be Well Medical Center, P.C.

Berkley, Michigan, 48072-3436, United States

Location

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

St Louis, Missouri, 63108, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

Harold Hamm Diabetes Center at the University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Fanno Creek Clinic, LLC

Portland, Oregon, 97219, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St. Hope Foundation, Inc.

Bellaire, Texas, 77401, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

UT Southwestern Medical Center, Atten: HIV Research Unit

Dallas, Texas, 75235, United States

Location

Research Access Network

Houston, Texas, 77098, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98112, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Marilyn De Chantal

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (24)