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Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050921
  Purpose

This study is designed to evaluate the ability of growth hormone (GH, also known as somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.


Condition Intervention
HIV Infections
Drug: somatropin
Biological: Hepatitis A virus, inactivated
Drug: Keyhole-Limpet Hemocyanin

MedlinePlus related topics: AIDS AIDS Medicines
Drug Information available for: Hepatitis A Vaccines Somatotropin Somatropin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Improving Immune Reconstitution With Growth Hormone in HIV-Infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 60
Detailed Description:

After initiation of HAART, many HIV infected patients have significant improvement in CD4+ levels. However, some patients continue to have low CD4+ counts (< 350 cells/mm3) despite adequate viral suppression. The purpose of this study is to determine whether administration of GH will increase naïve CD4+ production. Further, the study will assess whether an increase in naïve CD4+ production will lead to increases in antigen-specific CD4+ and CD8+ T cells.

Patients enrolled in this study will be randomized to one of two groups. Patients in both groups will continue their present HAART regimen for the duration of the study. Group A patients will receive daily subcutaneous injections of GH for 48 weeks. Group B participants will receive no additional therapy for 24 weeks, and will then receive daily subcutaneous GH injections during Weeks 24-28 of the study. Both groups will receive immunocyanin (keyhole-limpet hemocyanin) injections at Weeks 16 and 20 and hepatitis A vaccination at Weeks 40 and 44. At the conclusion of Week 48, all patients will discontinue GH therapy while maintaining their HAART regimen. Patients will then be followed for an additional 24 weeks.

Patients may be asked to participate in a substudy to measure the size of the thymus in people taking GH. Patients in the substudy will have a noncontrast CT scan of the chest before beginning GH therapy and again after 24 weeks of GH therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • HIV positive
  • Minimum of 1 year of treatment with HAART
  • CD4+ cell count <350 cells/mm3
  • HIV-1 RNA <400 copies/ml for 6 months prior to study entry
  • Acceptable methods of contraception

Exclusion Criteria

  • Serious medical illness requiring hospitalization within 14 days prior to study entry
  • Pregnant or breast-feeding
  • Taking certain medications
  • Allergy to r-hGH, hepatitis A vaccine, KLH, or their formulations, including allergies to shellfish
  • Active drug or alcohol dependence
  • Diabetes or uncontrolled hyperglycemia
  • Uncontrolled hypertension
  • History of carpal tunnel syndrome
  • Active neoplasm requiring treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050921

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35924-2050
United States, California
Univ of California, Davis Med Ctr
Sacramento, California, United States, 95814
UC Davis Med Ctr
Sacramento, California, United States, 95814
UCLA School of Medicine
Los Angeles, California, United States, 90095-1793
San Francicso General Hosp
San Francisco, California, United States, 94110
United States, Colorado
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, United States, 80262-3706
United States, Illinois
Rush-Presbyterian/St Lukes (Chicago)
Chicago, Illinois, United States, 60612
Northwestern Univ
Chicago, Illinois, United States, 60611-3015
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, Ohio
MetroHealth Med Ctr
Cleveland, Ohio, United States, 44109-1998
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106-5083
United States, Texas
Univ of Texas, Southwestern Med Ctr
Dallas, Texas, United States, 75235-9173
Sponsors and Collaborators
Investigators
Study Chair: Kimberly Smith, M.D., MPH Rush Medical College of Rush University
  More Information

Click here for more information about somatropin.  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG A5174, ACTG A5198s
Study First Received: December 30, 2002
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00050921  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Infections
CD4 Lymphocyte Count
Antiretroviral Therapy, Highly Active
Growth Hormone
Cell Division
CD4-Positive T-Lymphocytes
Treatment Experienced

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Keyhole-limpet hemocyanin
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009