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Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00050921
Recruitment Status : Completed
First Posted : January 1, 2003
Last Update Posted : November 1, 2021
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: somatropin Biological: Hepatitis A virus, inactivated Drug: Keyhole-Limpet Hemocyanin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hormones

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050921

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United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35924
United States, California
Los Angeles, California, United States, 90095
UC Davis Medical Center
Sacramento, California, United States, 95814
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States, 95814
Ucsf Aids Crs
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
United States, Iowa
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
United States, New York
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106
MetroHealth CRS
Cleveland, Ohio, United States, 44109
United States, Texas
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, United States, 75235
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Kimberly Smith, M.D., MPH Rush Medical College of Rush University

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050921    
Other Study ID Numbers: A5174
ACTG A5198s
10092 ( Registry Identifier: DAIDS ES Registry Number )
ACTG A5174
First Posted: January 1, 2003    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
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
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs