An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
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|ClinicalTrials.gov Identifier: NCT00000647|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: CD4-IgG Drug: Zidovudine Drug: Interferon alfa-n1 Procedure: Peripheral lymphocyte infusion Procedure: Bone marrow transplant||Not Applicable|
Based on previous studies showing temporary improvement in immune function in HIV-infected patients using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as well as the preliminary test tube and patient studies suggesting anti-HIV effects of recombinant CD4-IgG, we propose to treat HIV-infected patients using combination antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from previously immunized donors in an attempt to restore immunologic function and a virus-free state.
Three patients are treated with stable doses of AZT, IFN-A, and CD4-IgG for 12 weeks, followed by six peripheral lymphocyte infusions and transplantation of bone marrow from their respective identical twins. Following bone marrow transplantation, patients continue to receive the three drugs. Additional periods of lymphocyte apheresis and transfer may be offered to each donor/recipient pair.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||6 participants|
|Masking:||None (Open Label)|
|Official Title:||An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection|
|Actual Study Completion Date :||December 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000647
|United States, Maryland|
|Natl Inst of Allergy & Infect Dis / Cln Ctr|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||KM Zunich|