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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00050921

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2005-03-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• UCLA CARE Center CRS — Los Angeles, California, 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, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, 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

Full record on ClinicalTrials.gov

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