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

Exclusion Criteria

• •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.