Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)
4 other identifiers
interventional
60
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2002
CompletedFirst Posted
Study publicly available on registry
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedNovember 1, 2021
October 1, 2021
December 30, 2002
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Alabama Therapeutics CRS
Birmingham, Alabama, 35924, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
UC Davis Medical Center
Sacramento, California, 95814, United States
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95814, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, 52242, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
Case CRS
Cleveland, Ohio, 44106, United States
MetroHealth CRS
Cleveland, Ohio, 44109, United States
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, 75235, United States
Related 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. doi: 10.1086/315171.
PMID: 10608789BACKGROUNDSmith 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. doi: 10.1086/315169.
PMID: 10608760BACKGROUNDVigano 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. doi: 10.1097/00002030-200002180-00007.
PMID: 10716501BACKGROUNDSchambelan 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. doi: 10.7326/0003-4819-125-11-199612010-00002.
PMID: 8967667BACKGROUNDNapolitano 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. doi: 10.1097/00002030-200205240-00003.
PMID: 12004268BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kimberly Smith, M.D., MPH
Rush Medical College of Rush University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2002
First Posted
January 1, 2003
Study Completion
March 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10