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Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 Clinical research trials and Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1. Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 clinical trial. Subjects frequently obtain the most expert healthcare possible for their Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1 condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.

Home > "S" Clinical Trials Conditions > Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1

Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1



Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center ,
Synopsis: OBJECTIVES: I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1. II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population. III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population. IV. Determine the effect of this treatment regimen on viral load in this patient population.
Details: PROTOCOL OUTLINE: Patients receive oral or IV cyclosporine 2-3 times daily on Days -1 to 50. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0. Beginning within 6 hours of transplantation, patients receive oral mycophenolate mofetil every 12 hours until Day 27. Patients with an unstable level of chimerism may receive 1-2 donor lymphocyte infusions. Patients are followed at Days 14, 28, 56, 80, 180, and 360.
Eligibility:
Study Type:  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of human immunodeficiency virus-1 not responsive to highly active antiretroviral therapy (HAART); treated with HAART for at least the past 6 months; viral load less than 50 copies/mL plasma; CD4 count less than 100/mm3 - Lymphoma or other HIV-associated malignancy allowed with the following criteria: malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence of continued tumor growth; viral load has decreased by at least 1.5 logs OR to less than 5,000 copies/mL plasma while on HAART; CD4 count is allowed to be greater than 100/mm3 - HLA genotypically identical donor available (under 75 years of age) --Prior/Concurrent Therapy-- - No concurrent growth factors during mycophenolate mofetil administration; concurrent continuation of anti-retroviral therapy required --Patient Characteristics-- - Life expectancy: At least 30 days - Other: No positive serology for Toxoplasma gondii; no other disease or organ dysfunction that would preclude survival; not pregnant or nursing; fertile patients must use effective contraception during and for 1 year after study
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
AnnWoolfrey,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109
United States
Recruiting Ann  Woolfrey 206-667-4453


Additional Information:
Study ID Numbers:  199/15576;  FHCRC-1410.00
Study Start Date: November 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010348

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2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

3. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

4. A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine in Patients With AIDS and AIDS-Related Complex

5. Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

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