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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35924
        • Alabama Therapeutics CRS
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Center CRS
      • Sacramento, California, United States, 95814
        • UC Davis Medical Center
      • Sacramento, California, United States, 95814
        • Univ. of California Davis Med. Ctr., ACTU
      • San Francisco, California, United States, 94110
        • Ucsf Aids Crs
    • Colorado
      • Aurora, Colorado, United States, 80262
        • University of Colorado Hospital CRS
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ. of Iowa Healthcare, Div. of Infectious Diseases
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr., ACTU
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case CRS
      • Cleveland, Ohio, United States, 44109
        • MetroHealth CRS
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Kimberly Smith, M.D., MPH, Rush Medical College of Rush University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

December 30, 2002

First Submitted That Met QC Criteria

December 31, 2002

First Posted (ESTIMATE)

January 1, 2003

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5174
  • ACTG A5198s
  • 10092 (REGISTRY: DAIDS ES Registry Number)
  • ACTG A5174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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