Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome

You may not be if

• Must be taking antiretroviral medications that are approved or are available under a Treatment Investigational New Drug (IND). Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
• Must be willing and able to comply with the protocol for the duration of the study.
• Must have voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act of 1996 (HIPAA), prior to any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
• If female, subjects must either:
• * Be post menopausal (=/\>1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy), or
• * Use a contraceptive method for the duration of the study such as: hormonal contraceptive,intra uterine device,diaphragm with spermicide, or condom with spermicide, and
• * Must be neither pregnant nor breast feeding.
• * Confirmation that female subjects of childbearing potential are not pregnant must be established by a negative pregnancy test prior to initiating first treatment.
• A pregnancy test is not required if the subject is post menopausal or surgically sterilized.
• Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
• Have any active malignancy, except localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy).
• Have active central nervous system (CNS) process associated with neurological findings.
• Have acute illness treated in an intensive care unit, e.g., due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
• Have any medical condition in view of which the study doctor and/or Serono Medical/Therapeutic Director feels that it would be in the best interest of the subject not to participate in the follow-up study.
• Are unable to comply with the Concomitant Therapy restrictions as outlined in Section 5.5 and listed as follows:
• * Therapy for obesity including therapy with anorexigenic or fat reducing drugs.
• * Anti-diabetic or insulin sensitizing medications.
• * Systemic glucocorticoids.
• * Systemic chemotherapy, interferon or radiation therapy treatment.
• * Androgenic agents including, but not limited to, testosterone, nandrolone (Deca-durabolin), oxandrolone (Oxandrin), oxymetholone (Anadrol), dehydroepiandrosterone (DHEA), etc. (Testosterone replacement therapy for hypogonadism is the exception to this exclusion and will be allowed if started \>30 days prior to Study Day 1 of Serono Study 24380).
• * Progestational agents, unless used for oral contraception or post-menopausal hormone replacement therapy.
• * Appetite stimulants such as dronabinol (Marinol), megestrol acetate (Megace), or cyproheptadine (Periactin).
• * Investigational agents, unless approved in advance by Serono's Medical Director. Specifically, experimental antiretroviral agents are disallowed, unless available under a treatment IND or expanded access program (30 days).
• * Liposuction or other elective plastic surgery.
• * Acquired Immune Deficiency Syndrome (AIDS) wasting therapy with growth hormone and/or prior treatment with growth hormone or a growth hormone releasing factor (for 12 months prior to the screening visit).
• Are participating in any other clinical studies (except Serono Study 24380). Observation studies are allowed, but prior written permission by Serono Medical/Therapeutic Director must be granted.