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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00050921
• Collaborator: (none)
• Enrollment: 60
• Locations: 13
• Patients Per Site: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: somatropin; Biological: Hepatitis A virus, inactivated; Drug: Keyhole-Limpet Hemocyanin	N/A

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 Design

• Study Type: Interventional
• 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: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Therapeutics CRS	Birmingham	Alabama	United States	35924
2	UCLA CARE Center CRS	Los Angeles	California	United States	90095
3	UC Davis Medical Center	Sacramento	California	United States	95814
4	Univ. of California Davis Med. Ctr., ACTU	Sacramento	California	United States	95814
5	Ucsf Aids Crs	San Francisco	California	United States	94110
6	University of Colorado Hospital CRS	Aurora	Colorado	United States	80262
7	Northwestern University CRS	Chicago	Illinois	United States	60611
8	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois	United States	60612
9	Univ. of Iowa Healthcare, Div. of Infectious Diseases	Iowa City	Iowa	United States	52242
10	Beth Israel Med. Ctr., ACTU	New York	New York	United States	10003
11	Case CRS	Cleveland	Ohio	United States	44106
12	MetroHealth CRS	Cleveland	Ohio	United States	44109
13	Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic	Dallas	Texas	United States	75235

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00050921
• Other Study ID Numbers: A5174; ACTG A5198s; 10092; ACTG A5174
• First Posted: Jan 1, 2003
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): HIV Infections; CD4 Lymphocyte Count; Antiretroviral Therapy, Highly Active; Growth Hormone; Cell Division; CD4-Positive T-Lymphocytes; Treatment Experienced
• Additional relevant MeSH terms: HIV Infections; Keyhole-limpet hemocyanin

Study Results

No Results Posted as of Nov 1, 2021