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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050921
First received: December 30, 2002
Last updated: May 16, 2012
Last verified: May 2012

December 30, 2002
May 16, 2012
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Complete list of historical versions of study NCT00050921 on ClinicalTrials.gov Archive Site
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Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: somatropin
  • Biological: Hepatitis A virus, inactivated
  • Drug: Keyhole-Limpet Hemocyanin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050921
A5174, ACTG A5198s, 10092, ACTG A5174
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Kimberly Smith, M.D., MPH Rush Medical College of Rush University
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP