Growth Hormone in the Treatment of HIV-Associated Wasting

Exclusion Criteria

• •1. Any medical history of the following:
• •* Pancreatitis.
• •* Carpal tunnel syndrome (unless resolved by surgical release).
• •* Glucose intolerance \[for the purpose of this protocol defined as fasting blood glucose ≥ 110 mg/dl (6.1 mmol/l), or 2 hour/random blood glucose ≥ 140 mg/dl (7.8 mg/dl)\].
• •* Angina pectoris.
• •* Coronary artery disease.
• •* Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure, lymphedema).
• •* Allergy or hypersensitivity to growth hormone.
• •2. Any of the following medical conditions:
• •* Active AIDS-defining opportunistic infection.
• •* Any active malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which exceeds 2 cm in size, not on active therapy).
• •* A central nervous system (CNS) mass, or CNS process associated with active neurological findings.
• •* Chronic diarrhea (defined as 6 or more liquid stools per day).
• •* Unstable or untreated hypertension.
• •3. Patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure.
• •4. Either of the following aspects of the medical regimen in the 30 days prior to study entry (60 days prior to receiving study drug):
• •* New systemic therapy for opportunistic infection.
• •* New therapy for wasting, including parenteral or oral hyperalimentation, tube feeding, anabolic or progestational agents, or appetite stimulants.
• •5. Prior radiation therapy or systemic chemotherapy.
• •6. Use of glucocorticoids within the past six months or growth hormone within the past year.
• •7. An untreated or suspected serious systemic infection, or persistent fever \> 101°F (or 38.5°C) during the 30 days prior to study entry.
• •8. Evidence of gastrointestinal (GI) bleeding, obstruction, or malabsorption as determined by the Investigator.
• •9. Active substance abuse which would prevent informed consent or compliance with study activities.
• •10. Dementia which would preclude the patient from giving informed consent or complying with the requirements of this protocol.
• •11. If female, be neither pregnant or breast feeding.
• •12. Use of an investigational agent under another protocol unless discussed and approved in advance by Serono's Therapeutic Director.