A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulatio

• Conditions: HIV-associated lipodystrophy; MedDRA version: 8.1Level: LLTClassification code 10024608Term: Lipodystrophy

• Registration Number: EUCTR2006-005444-88-DE
• Lead Sponsor: Theratechnologies Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-14
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1.Subjects (male or female) aged 18 to 65 inclusive;
2.HIV positive with CD4 cell counts > 100 cells/mm3 and viral load < 10 000 copies/mL within 8 weeks prior to randomization;
3.On stable ART regimen for at least 8 weeks prior to randomization;
4.Have evidence of excess abdominal fat accumulation defined by the following anthropometrics cut off values, considered by the Investigator to be part of the HIV-associated lipodystrophy syndrome and occurring in the context of the treatment of HIV disease:
a.For males: Waist circumference greater than or equal to 95 cm and waist/hip ratio greater than or equal to 0.94
b.For females: Waist circumference greater than or equal to 94 cm and waist/hip ratio greater than or equal to 0.88;
5.Female subjects of childbearing potential are eligible only if they are not pregnant (negative pregnancy test) or lactating and they are:
a.pre-menopausal and using an acceptable form of birth control prior to study entry and for at least 2 months after completing the treatment,
b.or surgically sterilized (tubal ligation or hysterectomy),
c.or post-menopausal with no menses for > 1 year;
6.For all female subjects, normal mammography within 6 months of randomization;
7.Have sufficient literacy to read, understand and complete the self-administered patient-reported outcomes questionnaire, as well as all study questionnaires;
8.Signed informed consent before any trial-related activities.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Body Mass Index less than or equal to 20 kg/m2;
2.Opportunistic infection or HIV-related disease within 3 months of randomization;
3.History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months);
4.For male subjects, suspicion of cancer by prostate examination and PSA > 5 ng/ml at screening;
5.For female subjects, history of breast cancer or proven maternal family history of breast cancer;
6.Hypopituitarism, or history of pituitary tumor/surgery, head irradiation or head trauma that has affected the somatotrophic axis;
7.Untreated hypothyroidism;
8.Co-morbid condition that will not allow the subject to complete the study as per the Investigator’s judgment;
9.Evidence of the following at screening:
a.Hepatic dysfunction: ALT or AST greater than or equal to 3 x ULN
b.Renal dysfunction: serum creatinine > 133 micromol/L (1.5 mg/dL)
c.Anemia: hemoglobin more than 20 g/L below LLN
d.Fasting blood glucose greater than or equal to 8.33 mmol/L (150 mg/dL)
e.Lipid metabolism dysfunction: fasting triglycerides > 11.3 mmol/L (0.99 g/dL);
10.Uncontrolled hypertension defined as systolic pressure > 140 mmHg and diastolic pressure > 90 mmHg;
11.Use of any hypoglycemic or insulin-sensitizing agent within 6 months of randomization (except subjects previously treated with insulin during pregnancy and where insulin was not required after delivery) and throughout the study;
12.Change in anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is not exclusionary;
13.Supraphysiological dose of testosterone [e.g. > 10 mg/day of transdermal testosterone, > 10 g/day of topical/gel testosterone, or > 100 mg/week of IM testosterone (e.g. 200 mg/2 weeks, 300 mg/3 weeks or 400 mg/month), or their equivalent] within 6 months prior to randomization and throughout the study;
14.Change in physiological testosterone regimen within 6 months prior to randomization. Use of stable physiologic testosterone during the study is not exclusionary;
15.Use of anabolic steroids within 6 months prior to randomization and throughout the study;
16.Therapy with estrogen within 2 months prior to randomization and throughout the study;
17.Use of any prescription weight loss agent (anorectics, anorexigenics or anti-obesity agents), appetite stimulant or antianorectic agents within 3 months prior to randomization and throughout the study;
18.Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1 or IGFBP-3 within 6 months prior to randomization and throughout the study;
19.Prior use of TH9507;
20.Drug or alcohol dependence within 6 months prior to randomization;
21.Use of methadone within 6 months prior to randomization;
22.Participation in a clinical trial with any investigational drug/device within 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate a reduction in visceral adipose tissue (VAT) versus placebo.;Secondary Objective: 1.To demonstrate the efficacy of TH9507 versus placebo in:<br>a.Subject reported outcomes related to body image<br>b.Total cholesterol/ HDL-Cholesterol ratio and triglycerides levels <br>c.IGF-1 levels <br>2.To characterize the safety profile of TH9507 treatment in HIV subjects with excess abdominal fat accumulation.<br>;Primary end point(s): The primary efficacy endpoint is the percent change from baseline to week 26 in VAT (Visceral Adipose Tissue)