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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


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

Estimated Enrollment: 60
Study Completion Date: March 2005
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
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: NCT00050921

Locations
United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35924
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States, 95814
UC Davis Medical Center
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
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
Northwestern University CRS
Chicago, Illinois, United States, 60611
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
MetroHealth CRS
Cleveland, Ohio, United States, 44109
Case CRS
Cleveland, Ohio, United States, 44106
United States, Texas
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Investigators
Study Chair: Kimberly Smith, M.D., MPH Rush Medical College of Rush University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050921     History of Changes
Other Study ID Numbers: A5174, ACTG A5198s, 10092, ACTG A5174
Study First Received: December 30, 2002
Last Updated: May 16, 2012
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Hormones
Keyhole-limpet hemocyanin
Anti-HIV Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014