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

• ClinicalTrials.gov Identifier: NCT00050921
• Recruitment Status: Completed
• First Posted: January 1, 2003
• Last Update Posted: May 18, 2012
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information

• First Submitted Date: December 30, 2002
• First Posted Date: January 1, 2003
• Last Update Posted Date: May 18, 2012
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00050921 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
• Official Title: Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)
• Brief Summary: 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections

Intervention

• Drug: somatropin
• Biological: Hepatitis A virus, inactivated
• Drug: Keyhole-Limpet Hemocyanin

• Study Arms: Not Provided

Publications *

• Connick E, Lederman MM, Kotzin BL, Spritzler J, Kuritzkes DR, St Clair M, Sevin AD, Fox L, Chiozzi MH, Leonard JM, Rousseau F, D'Arc Roe J, Martinez A, Kessler H, Landay A. Immune reconstitution in the first year of potent antiretroviral therapy and its relationship to virologic response. J Infect Dis. 2000 Jan;181(1):358-63.
• Smith KY, Valdez H, Landay A, Spritzler J, Kessler HA, Connick E, Kuritzkes D, Gross B, Francis I, McCune JM, Lederman MM. Thymic size and lymphocyte restoration in patients with human immunodeficiency virus infection after 48 weeks of zidovudine, lamivudine, and ritonavir therapy. J Infect Dis. 2000 Jan;181(1):141-7.
• Vigano A, Vella S, Saresella M, Vanzulli A, Bricalli D, Di Fabio S, Ferrante P, Andreotti M, Pirillo M, Dally LG, Clerici M, Principi N. Early immune reconstitution after potent antiretroviral therapy in HIV-infected children correlates with the increase in thymus volume. AIDS. 2000 Feb 18;14(3):251-61.
• Schambelan M, Mulligan K, Grunfeld C, Daar ES, LaMarca A, Kotler DP, Wang J, Bozzette SA, Breitmeyer JB. Recombinant human growth hormone in patients with HIV-associated wasting. A randomized, placebo-controlled trial. Serostim Study Group. Ann Intern Med. 1996 Dec 1;125(11):873-82.
• Napolitano LA, Lo JC, Gotway MB, Mulligan K, Barbour JD, Schmidt D, Grant RM, Halvorsen RA, Schambelan M, McCune JM. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002 May 24;16(8):1103-11.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2005
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00050921
• Other Study ID Numbers: A5174; ACTG A5198s; 10092 ( Registry Identifier: DAIDS ES Registry Number ); ACTG A5174
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• Study Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Institute of Allergy and Infectious Diseases (NIAID)
• Verification Date: May 2012