TH9507 in Patients With HIV-Associated Lipodystrophy
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ClinicalTrials.gov Identifier: NCT00123253 |
Recruitment Status :
Completed
First Posted : July 22, 2005
Last Update Posted : November 27, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Lipodystrophy | Drug: TH9507 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 412 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 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 Patients With Excess of Abdominal Fat Accumulation |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | April 2007 |

- Visceral adipose tissue (VAT)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 18 to 65 years inclusive
- HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for 8 weeks)
- On stable ART regimen for at least 8 weeks prior to randomization
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Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
- For males: waist circumference > 95 cm and waist to hip ratio > 0.94;
- For females: waist circumference > 94 cm and waist to hip ratio > 0.88.
- Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
- Signed informed consent
Exclusion Criteria:
- Body mass index < 20 kg/m2
- Opportunistic infection; HIV-related disease within 3 months of study.
- History of malignancy; active neoplasm.
- Prostate-specific antigen (PSA) >5 ng/mL at screening
- Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
- Untreated hypothyroidism
- Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
- ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting triglycerides > 11.3 mmol/L (0.99 g/dL).
- Untreated hypertension
- Change in anti-hyperlipemic regimen within 3 months prior to study
- Change in testosterone regimen and/or supraphysiological dose of testosterone
- Estrogen therapy
- Anoretics/anorexigenics or anti-obesity agents within 3 months of study
- Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
- Drug or alcohol dependence or use of methadone within 6 months of study entry
- Participation in a clinical trial with any investigational drug/device within 30 days of screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123253

Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00123253 |
Obsolete Identifiers: | NCT00435136 |
Other Study ID Numbers: |
TH9507/III/LIPO/010 |
First Posted: | July 22, 2005 Key Record Dates |
Last Update Posted: | November 27, 2013 |
Last Verified: | November 2013 |
HIV Lipodystrophy Abdominal fat accumulation Growth hormone releasing factor/Growth hormone releasing hormone Treatment Experienced |
Lipodystrophy Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders |
Metabolic Diseases Tesamorelin Growth Substances Physiological Effects of Drugs |