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Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs Clinical research trials and Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs. Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs clinical trial. Human subjects often receive the most effective healthcare possible for their Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs  Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
KimberlySmith, Study Chair, Rush Medical College of Rush University
San Francicso General Hosp
San Francisco, California, 94110
United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262-3706
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106-5083
United States
UC Davis Med Ctr
Sacramento, California, 95814
United States
Univ of Texas, Southwestern Med Ctr
Dallas, Texas, 75235-9173
United States
UCLA School of Medicine
Los Angeles, California, 90095-1793
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35924-2050
United States
Northwestern Univ
Chicago, Illinois, 60611-3015
United States
Univ of California, Davis Med Ctr
Sacramento, California, 95814
United States
Rush-Presbyterian/St Lukes (Chicago)
Chicago, Illinois, 60612
United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Additional Information:
Study ID Numbers: ACTG A5174; ACTG A5198s
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050921
Other Hiv Infections Studies:
1. A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
2. A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
3. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
4. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
5. A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs
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