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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Hormones; Keyhole-limpet hemocyanin

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