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

Exclusion criteria

• Have an active acquired immune deficiency syndrome (AIDS)-defining Opportunistic Infection (OI) as defined by the Center for Disease Control; or have had an untreated or suspected serious systemic infection, or persistent fever greater than or equal to 101 degree Fahrenheit (°F) (38.3 degree Celsius) during the 30 days prior to study entry
• Have any active malignancy, except for localized cutaneous Karposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy)
• Have a central nervous system (CNS) mass or active CNS process associated with neurological findings
• Have unstable or untreated hypertension, defined as greater than or equal to 140/90 millimeter of mercury (mmHg) at the time of the Screening Visit, and/or has initiated or changed antihypertensive therapy in the 30 days prior to Day 1
• Have an acute critical illness treated in an intensive care unit, for example, due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure
• Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia
• Is unable to comply with the concomitant therapy restrictions
• Have ever been diagnosed with any of the following conditions:

• Pancreatitis
• Carpal tunnel syndrome (unless resolved by surgical release)
• Diabetes mellitus
• Angina pectoris
• Coronary artery disease
• Any disorder associated with moderate to severe edema (for example, cirrhosis, nephrotic syndrome, congestive heart failure, lymphedema)
• Allergy or hypersensitivity to growth hormone