Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: somatropin (Drug); Hepatitis A virus, inactivated (Biological); Keyhole-Limpet Hemocyanin (Drug)
Status: No longer recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Official(s) and/or principal investigator(s):
Kimberly Smith, M.D., MPH, Study Chair, Affiliation: Rush Medical College of Rush University
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.
Improving Immune Reconstitution With Growth Hormone in HIV-Infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)
Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.
Minimum age: 18 Years.
- 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
- 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
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35924-2050, United States
Univ of California, Davis Med Ctr, Sacramento, California 95814, United States
UC Davis Med Ctr, Sacramento, California 95814, United States
UCLA School of Medicine, Los Angeles, California 90095-1793, United States
San Francicso General Hosp, San Francisco, California 94110, United States
Univ of Colorado Health Sciences Ctr, Denver, Denver, Colorado 80262-3706, United States
Rush-Presbyterian/St Lukes (Chicago), Chicago, Illinois 60612, United States
Northwestern Univ, Chicago, Illinois 60611-3015, United States
Beth Israel Med Ctr, New York, New York 10003, United States
MetroHealth Med Ctr, Cleveland, Ohio 44109-1998, United States
Case Western Reserve Univ, Cleveland, Ohio 44106-5083, United States
Univ of Texas, Southwestern Med Ctr, Dallas, Texas 75235-9173, United States
Click here for more information about somatropin.
Haga clic aquí para ver información sobre este ensayo clínico en español.
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Last updated: March 31, 2006