TH9507 in Patients With HIV-Associated Lipodystrophy

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 * 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 the…