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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00050921 |
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 |
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HIV Infections |
Drug: somatropin Biological: Hepatitis A virus, inactivated Drug: Keyhole-Limpet Hemocyanin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Immune Reconstitution With Growth Hormone in HIV-Infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART) |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35924-2050 | |
United States, California | |
Univ of California, Davis Med Ctr | |
Sacramento, California, United States, 95814 | |
UC Davis Med Ctr | |
Sacramento, California, United States, 95814 | |
UCLA School of Medicine | |
Los Angeles, California, United States, 90095-1793 | |
San Francicso General Hosp | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr, Denver | |
Denver, Colorado, United States, 80262-3706 | |
United States, Illinois | |
Rush-Presbyterian/St Lukes (Chicago) | |
Chicago, Illinois, United States, 60612 | |
Northwestern Univ | |
Chicago, Illinois, United States, 60611-3015 | |
United States, New York | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, Ohio | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 44109-1998 | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106-5083 | |
United States, Texas | |
Univ of Texas, Southwestern Med Ctr | |
Dallas, Texas, United States, 75235-9173 |
Study Chair: | Kimberly Smith, M.D., MPH | Rush Medical College of Rush University |
Study ID Numbers: | ACTG A5174, ACTG A5198s |
Study First Received: | December 30, 2002 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00050921 |
Health Authority: | United States: Food and Drug Administration |
HIV Infections CD4 Lymphocyte Count Antiretroviral Therapy, Highly Active Growth Hormone |
Cell Division CD4-Positive T-Lymphocytes Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Keyhole-limpet hemocyanin Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases Physiological Effects of Drugs |
Adjuvants, Immunologic Lentivirus Infections Infection Pharmacologic Actions |