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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 November 2021 |
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Main ID: |
NCT00050921 |
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Date of registration:
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30/12/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
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Scientific title:
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Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART) |
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Date of first enrolment:
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October 31, 2002 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00050921 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Kimberly Smith, M.D., MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush Medical College of Rush University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Biological: Hepatitis A virus, inactivated
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Drug: Keyhole-Limpet Hemocyanin
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Drug: somatropin
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Secondary ID(s)
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A5174
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ACTG A5198s
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10092
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ACTG A5174
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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