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

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Infections, Lipodystrophy

In brief

The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

Key facts

Study ID

NCT00082628

Run by

EMD Serono

People needed

326

Starts

2004-05-28

Expected to finish

2005-09-28

Last updated by the study team

2018-07-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have written laboratory documentation of an HIV infection by one of the following methods:
• 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 immunofluorescence assay.
• Written laboratory documentation of an HIV infection must be obtained prior to randomization. In the absence of documented historical confirmation, an assay of HIV antibodies will be included in the Screening Laboratory Panel. Results will be confirmed with a Western Blot.
• Have evidence of excess abdominal adipose deposition when measured by the anthropometric 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.
• Are taking antiretroviral medication(s) which is (are) approved or is (are) available under a Treatment IND. The regimen must have remained stable for 30 days prior to study entry. Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
• Have parameter values less than the following limits (using results from the central laboratory):
• 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).
• Weight >= 36 kg (79.3 lb)
• Be between 18 and 60 years of age (inclusive) unless local law dictates different limits.
• Sufficiently literate in English to be able to comprehend and complete the Quality of Life Questionnaire.
• Willing and able to comply with the protocol for the duration of the study.
• Have voluntarily provided written informed consent (with subject authorization under HIPAA), prior to performing 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.
• Female subjects must:
• 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.

You may not qualify if…

• Have an active AIDS-defining opportunistic complication (OC) as defined by the CDC or have had an untreated or suspected serious systemic infection, or have had a persistent fever >= 101°F (38.3°C) during the 30 days prior to study entry.
• Any active or past history of malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy). Such exceptions must be confirmed in writing by the Serono Study Director.
• Have a CNS mass or active CNS process associated with neurological findings.
• Have unstable or untreated hypertension, defined as >= 140/90 mm Hg at the time of the Screening Visit, and/or have initiated or changed antihypertensive therapy in the 30 days prior to Study Day 1.
• Have an acute critical 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 a recent history of sleep apnea or intermittent upper respiratory obstruction.
• Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
• 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 for hypogonadism 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-menopausal hormone replacement therapy
• appetite stimulants
• investigational agents, unless approved in advance by the study 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
• AIDS wasting therapy or prior growth hormone treatment other than study drug (for 12 months prior to the screening visit)
• 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, nephrotic syndrome, congestive heart failure, lymphedema).

Where it is running

• University of Alabama/Birmingham — Birmingham, Alabama, United States
• CARE CLINIC - UCLA Medical Center — Los Angeles, California, United States
• 1401 N. Palm Canyon — Palm Springs, California, United States
• Trials Unit Div of Infectious and Immunologic Diseases — Sacramento, California, United States
• UCSD - AntiViral Research Center — San Diego, California, United States
• University of California, San Francisco - Div. of Endocrinology — San Francisco, California, United States
• Kaiser Permanente — San Francisco, California, United States
• Northern California Institute for Research and Education, Inc. — San Francisco, California, United States
• Harbor-UCLA Medical Ctr Research & Education Institute — Torrance, California, United States
• AIDS Alliance — West Hollywood, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• 1640 Rhode Island Avenue, N.W. — Washington D.C., District of Columbia, United States
• Office Of Dr Gary Richmond — Fort Lauderdale, Florida, United States
• 3661 South Miami Avenue — Miami, Florida, United States
• Care Resources — Miami, Florida, United States
• Infectious Disease Associates — Sarasota, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Tufts University School of Medicine — Boston, Massachusetts, United States
• Community Research Initiative of New England — Boston, Massachusetts, United States
• Community Research Initiative Of New England — Springfield, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Albany Medical College — Albany, New York, United States
• Weill Medical College of Cornell Universtiy — New York, New York, United States

Full record on ClinicalTrials.gov

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