|
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection Clinical research trials and A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection. A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection  A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring who has a compatible blood type). To measure the distribution and survival of allogeneic lymphocytes in the circulation of HIV-infected patients, and to determine whether their infusion results in enhanced immunity. To determine whether enhanced immunity is passively transferred or actively induced. There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy.
Details: There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy. Lymphocytes obtained by leukapheresis from a healthy, HIV-negative parent, sibling, or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8. A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion, and two total body scans will be performed. Patients also undergo two tonsillar biopsies. Patients are followed weekly for 16 weeks, then by telephone periodically for 3 years (at 1 year, 2 years, 2.5 years, and 3 years).
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Stable antiretroviral therapy. Allowed: - Maintenance therapy for a controlled opportunistic infection. Patients must have: - HIV infection. - CD4 count 50-200 cells/mm3. - No ongoing major opportunistic infections. - Been on stable antiretroviral therapy for the past 2 months. - Tonsils present. - Life expectancy greater than 6 months. - An HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Lymphoma or other malignancy requiring chemotherapy. - Bleeding disorder that would preclude a tonsillar biopsy. - Antibody on donor/recipient lymphocyte reactive antibody assay. Donors with the following symptoms or conditions are excluded: - Medical condition that would endanger health of donor or recipient. - Failure to meet established donor standards on blood screening tests. - CMV seropositivity if the patient (recipient) is CMV seronegative. - Pregnancy. Concurrent Medication: Excluded: - GM-CSF or G-CSF. - Any investigational drug. - Immunomodulators (such as interferon, steroids, topical corticosteroids, thalidomide, pentoxifylline, IL-2). - Nonsteroidal anti-inflammatory drugs. - Aspirin. Prior Treatment: Excluded: - Blood transfusion within the past 2 months. Required: - Stable antiretroviral therapy for at least 2 months prior to study entry. Active substance abuse.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
LedermanM, Study Chair,
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: DATRI 016;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000852
Other Hiv Infections Studies:
1. A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults
2. A Study of Isoprinosine in Patients with Severe AIDS
3. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
4. A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
5. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
|
|
|
|
|
|
|
|
