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Growth Hormone in the Treatment of HIV-Associated Wasting



Growth Hormone in the Treatment of HIV-Associated Wasting

For Condition: HIV Wasting Syndrome,HIV Infections
Status: Completed
Sponsor(s): Serono ,
Synopsis: The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.
Details: Patients are selected randomly to receive full-dose somatropin, half-dose somatropin, or placebo. Clinical assessments are taken at Week 12. Patients who reach the primary study endpoint will be eligible for a 12-week ancillary course of somatropin treatment at the full dose.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Have HIV infection. - Have HIV/AIDS wasting or severe weight loss or malnutrition. - Are at least 18 years old. - Meet treatment, medication, and nutrition requirements. - Are taking anti-HIV medications.
Total Enrollment: 732

Location and Contact Information:

Clinical Trial Information
Norwell,  Massachusetts,  02061
United States
 


Additional Information:
Study ID Numbers:
  317A;  GF9037
Study Start Date: 
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013988

Other Hiv Wasting Syndrome Studies:
1. A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected with HIV-1

2. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome

3. Treatment with Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

4. A Study of Amprenavir in HIV-Infected Patients

5. Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients with CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Have Received Antiretroviral Treatment

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Growth Hormone in the Treatment of HIV-Associated Wasting

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