Treatment of Abnormal Adipose Tissue Accumulation in HIV Patients

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00082628
First received: May 13, 2004
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Lipodystrophy
Drug: Serostim®[somatropin (rDNA origin) for injection]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Enrollment: 569
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. 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.
  4. 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).
  5. Weight >= 36 kg (79.3 lb)
  6. Be between 18 and 60 years of age (inclusive) unless local law dictates different limits.
  7. Sufficiently literate in English to be able to comprehend and complete the Quality of Life 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 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.
  10. Female subjects must:

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

      or

    2. 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 must be established by a negative beta-hCG serum pregnancy test during the 14-day screening period prior to Study Day 1. If the beta-hCG serum pregnancy test is performed more than 7 days prior to Study Day 1, a urine pregnancy test must be performed by the site laboratory on Study Day 1 to confirm a negative test result.

Exclusion Criteria:

  1. 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.
  2. 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.
  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 the Screening Visit, and/or have initiated or changed antihypertensive therapy in the 30 days prior to Study Day 1.
  5. 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.
  6. Have a recent history of sleep apnea or intermittent upper respiratory obstruction.
  7. Have any condition, which interferes with informed consent or protocol compliance including, 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 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)
  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, nephrotic syndrome, 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 and exclusion criteria specified above. Requests for protocol exceptions/exemptions must come from a participating, fully initiated site at which a prospective patient has consented to undergo screening. Exceptions/exemptions are only allowed by the Trial Director. There is no program in place to allow drug for a single patient IND, or for an expanded access protocol. This statement holds true for both children and adults.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082628

  Hide Study Locations
Locations
United States, Alabama
University of Alabama/Birmingham
Birmingham, Alabama, United States, 35294
United States, California
CARE CLINIC - UCLA Medical Center
Los Angeles, California, United States, 90095
1401 N. Palm Canyon
Palm Springs, California, United States, 92262
Trials Unit Div of Infectious and Immunologic Diseases
Sacramento, California, United States, 95817
UCSD - AntiViral Research Center
San Diego, California, United States, 92103
University of California, San Francisco - Div. of Endocrinology
San Francisco, California, United States, 94110
Kaiser Permanente
San Francisco, California, United States, 94118
Northern California Institute for Research and Education, Inc.
San Francisco, California, United States, 94121
Harbor-UCLA Medical Ctr Research & Education Institute
Torrance, California, United States, 90502
AIDS Alliance
West Hollywood, California, United States, 90069
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, District of Columbia
1640 Rhode Island Avenue, N.W.
Washington, District of Columbia, United States, 20036
United States, Florida
Office Of Dr Gary Richmond
Fort Lauderdale, Florida, United States, 33316
3661 South Miami Avenue
Miami, Florida, United States, 33133
Care Resources
Miami, Florida, United States, 33137
Infectious Disease Associates
Sarasota, Florida, United States, 34239
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
Community Research Initiative Of New England
Springfield, Massachusetts, United States, 01107
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Bronx Women's Interagency HIV Study
Bronx, New York, United States, 10467
St. Luke's Roosevelt Hospital
New York, New York, United States, 10025
Weill Medical College of Cornell Universtiy
New York, New York, United States, 10021
United States, Texas
Central Texas Clincial research
Austin, Texas, United States, 78705
United States, Virginia
IDP Research
Annandale, Virginia, United States, 22003
United States, Washington
Office of Daniel Coulston, M.D.
Spokane, Washington, United States, 99204
Canada, British Columbia
AIDS Research Program
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Norma Muurahainen, MD Sponsor GmbH
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00082628     History of Changes
Other Study ID Numbers: 24380
Study First Received: May 13, 2004
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
growth hormone
Serostim®
Human Adipose Redistribution Syndrome
Human Immunodeficiency Virus lipodystrophy
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014