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.
• +16 more criteria