Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

Inclusion Criteria

• •Have an Human Immunodeficiency Virus (HIV) infection documented either by viral load as measured by polymerase chain reaction (PCR) amplification; or by the presence of HIV antibodies with confirmation by one of the following:
• •Western blot
• •Immunofluorescence assay
• •Branched Deoxyribonucleic Acid (bDNA) signal amplification
• •The presence of p24 antigen
• •These tests may have been performed at any time in the past, but the results must be available for review by the Serono monitor prior to randomization
• •Have evidence of excess abdominal adipose deposition when measured using the following cut points:
• •* Men: Waist circumference greater than 88.2 centimeter (cm) and waist/hip ratio greater than or equal to 0.95
• •* Women: Waist circumference greater than 75.3 cm and waist/hip ratio greater than or equal to 0.9 (23)
• •Be taking antiretroviral medication(s) which is (are) approved or is (are) available under a treatment investigational new drug (IND). The regimen must have remained stable for the 30 days prior to study entry. Subjects must also have agreed not to discontinue or to change their regimen for the duration of the study except as judged medically necessary
• •Have parameter values less than the following limits:
• •* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and amylase less than or equal to 3 times the upper limit of normal (Screening)
• •* Fasting triglycerides less than or equal to 1,000 milligram per deciliter (mg/dL) (Screening)
• •* Fasting glucose less than 110 mg/dL (Screening)
• •* Two hour (120 minute) glucose less than 140 mg/dL (following an oral glucose load at Screening)
• •Weigh greater than or equal to 36 kilogram (kg) (79.3 pound)
• •Be between 18 and 60 years of age unless local law dictates different limits
• •Be able and willing to comply with the protocol for the duration of the study
• •Have given written informed consent
• •If female, be post-menopausal or surgically sterilized (that is, have undergone tubal ligation or hysterectomy), or is
• •* Using a contraceptive method such as a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
• •* Not pregnant or breast feeding