Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

Inclusion Criteria:

1. Have written laboratory documentation of an HIV infection by one of the followingmethods:

• Detectable viral load measured by polymerase chain reaction (PCR) amplification,branched chain DNA (bDNA) signal amplification or the presence of p24 antigen.

• Presence of HIV antibodies confirmed by either Western blot or immunofluorescenceassay. Written laboratory documentation of an HIV infection must be obtained prior torandomization. In the absence of documented historical confirmation, an assay of HIVantibodies will be included in the Screening Laboratory Panel. Results will beconfirmed with a Western Blot.

2. Have evidence of excess abdominal adipose deposition when measured by theanthropometric methodology, using the following cut off values:

• Men: Waist circumference >88.2 cm AND waist: hip ratio >= 0.95.

• Women: Waist circumference >75.3 cm AND waist: hip ratio >= 0.9.

3. Are taking antiretroviral medication(s) which is (are) approved or is (are) availableunder a Treatment IND. The regimen must have remained stable for 30 days prior tostudy entry. Subjects must also agree not to discontinue or to change their regimenfor the duration of the study except as judged medically necessary.

4. Have parameter values less than the following limits (using results from the centrallaboratory):

• AST, ALT, and amylase <= 3 times the upper limit of normal (Screening).

• Fasting triglycerides <= 1,000 mg/dL (Screening).

• Fasting glucose <110 mg/dL (Screening).

• Two-hour (120 minute) glucose <140 mg/dL (Screening).

5. Weight >= 36 kg (79.3 lb)

6. Be between 18 and 60 years of age (inclusive) unless local law dictates differentlimits.

7. Sufficiently literate in English to be able to comprehend and complete the Quality ofLife Questionnaire.

8. Willing and able to comply with the protocol for the duration of the study.

9. Have voluntarily provided written informed consent (with subject authorization underHIPAA), prior to performing any study-related procedure that is not part of normalmedical care, and with the understanding that the subject may withdraw consent at anytime without prejudice to future medical care.

10. Female subjects must:

11. Be post menopausal (>= 1 year) or surgically sterilized (i.e., have undergonetubal ligation or hysterectomy) or

12. 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

3. Must be neither pregnant nor breast feeding.

4. Confirmation that female subjects of childbearing potential are not pregnant mustbe established by a negative beta-hCG serum pregnancy test during the 14-dayscreening period prior to Study Day 1. If the beta-hCG serum pregnancy test isperformed more than 7 days prior to Study Day 1, a urine pregnancy test must beperformed by the site laboratory on Study Day 1 to confirm a negative testresult.

Exclusion Criteria:

1. Have an active AIDS-defining opportunistic complication (OC) as defined by the CDC orhave had an untreated or suspected serious systemic infection, or have had apersistent fever >= 101°F (38.3°C) during the 30 days prior to study entry.

2. Any active or past history of malignancy, except for localized cutaneous Kaposi'ssarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on activetherapy). Such exceptions must be confirmed in writing by the Serono Study Director.

3. Have a CNS mass or active CNS process associated with neurological findings.

4. Have unstable or untreated hypertension, defined as >= 140/90 mm Hg at the time of theScreening Visit, and/or have initiated or changed antihypertensive therapy in the 30days prior to Study Day 1.

5. Have an acute critical illness treated in an intensive care unit, e.g., due tocomplications following open heart or abdominal surgery, multiple accidental trauma,or acute respiratory failure.

6. Have a recent history of sleep apnea or intermittent upper respiratory obstruction.

7. Have any condition, which interferes with informed consent or protocol complianceincluding, but not limited to, active substance abuse and/or dementia.

8. Are unable to comply with the Concomitant Therapy restrictions including:

• 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,oxandrolone, oxymetholone, etc. (testosterone replacement therapy forhypogonadism is the exception to this exclusion and will be allowed if started > 30 days prior to Study Day 1)

• progestational agents, unless used for oral contraception or post-menopausalhormone replacement therapy

• appetite stimulants

• investigational agents, unless approved in advance by the study medical director.Specifically, experimental antiretroviral agents are disallowed, unless availableunder a treatment IND or expanded access program (30 days).

• Liposuction or other elective plastic surgery

• AIDS wasting therapy or prior growth hormone treatment other than study drug (for 12 months prior to the screening visit)

9. 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 (e.g., ascites, nephroticsyndrome, congestive heart failure, lymphedema).

10. Allergy or hypersensitivity to growth hormone.

11. Are participating in any other clinical studies. In order to participate in this trial a subject must meet all of the inclusion andexclusion criteria specified above. Requests for protocol exceptions/exemptions must comefrom a participating, fully initiated site at which a prospective patient has consented toundergo screening. Exceptions/exemptions are only allowed by the Trial Director. There isno program in place to allow drug for a single patient IND, or for an expanded accessprotocol. This statement holds true for both children and adults.