Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: somatropin Biological: Hepatitis A virus, inactivated Drug: Keyhole-Limpet Hemocyanin | Not Applicable |
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 (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 |


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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

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
United States, Alabama | |
Alabama Therapeutics CRS | |
Birmingham, Alabama, United States, 35924 | |
United States, California | |
UCLA CARE Center CRS | |
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 |
Study Chair: | Kimberly Smith, M.D., MPH | Rush Medical College of Rush University |
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 |
HIV Infections CD4 Lymphocyte Count Antiretroviral Therapy, Highly Active Growth Hormone |
Cell Division CD4-Positive T-Lymphocytes Treatment Experienced |
HIV Infections 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 |