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	Treatment or Intervention
HIV Infections	Drug: somatropin  Vaccine: Hepatitis A virus, inactivated  Drug: Keyhole-Limpet Hemocyanin

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35924-2050,  United States
California
      Univ of California, Davis Med Ctr, Sacramento,  California,  95814,  United States
      UC Davis Med Ctr, Sacramento,  California,  95814,  United States
      UCLA School of Medicine, Los Angeles,  California,  90095-1793,  United States
      San Francicso General Hosp, San Francisco,  California,  94110,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver, Denver,  Colorado,  80262-3706,  United States
Illinois
      Rush-Presbyterian/St Lukes (Chicago), Chicago,  Illinois,  60612,  United States
      Northwestern Univ, Chicago,  Illinois,  60611-3015,  United States
New York
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
Ohio
      MetroHealth Med Ctr, Cleveland,  Ohio,  44109-1998,  United States
      Case Western Reserve Univ, Cleveland,  Ohio,  44106-5083,  United States
Texas
      Univ of Texas, Southwestern Med Ctr, Dallas,  Texas,  75235-9173,  United States

Study chairs or principal investigators

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

Study ID Numbers:  ACTG A5174; ACTG A5198s
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  December 30, 2002
ClinicalTrials.gov Identifier:  NCT00050921
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08