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NCT00050921 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00050921
Other study ID # A5174
Secondary ID ACTG A5198s10092
Status Completed
Phase N/A
First received
Last updated
Est. completion date March 2005

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Biological:
• Hepatitis A virus, inactivated

Drug:
• Keyhole-Limpet Hemocyanin

Locations
Country Name City State
United States University of Colorado Hospital CRS Aurora Colorado
United States Alabama Therapeutics CRS Birmingham Alabama
United States Northwestern University CRS Chicago Illinois
United States Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois
United States Case CRS Cleveland Ohio
United States MetroHealth CRS Cleveland Ohio
United States Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic Dallas Texas
United States Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City Iowa
United States UCLA CARE Center CRS Los Angeles California
United States Beth Israel Med. Ctr., ACTU New York New York
United States UC Davis Medical Center Sacramento California
United States Univ. of California Davis Med. Ctr., ACTU Sacramento California
United States Ucsf Aids Crs San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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