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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
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date October 27, 2021
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary To restore immunologic function and virus-free state in HIV-infected patients. 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: CD4-IgG
  • Drug: Zidovudine
  • Drug: Interferon alfa-n1
  • Procedure: Peripheral lymphocyte infusion
  • Procedure: Bone marrow transplant
Study Arms  ICMJE Not Provided
Publications * Zunich KM, Easter M, Owen C, Walker R, Davey R, Wilson W, Leitman S, Fauci AS, Lane HC. Bone marrow transplantation and adoptive transfer of peripheral blood lymphocytes from gp160-immunized syngeneic donors combined with zidovudine, interferon-alpha, and recombinant CD4-IgG in the treatment of HIV infection. Int Conf AIDS. 1991 Jun 16-21;7(2):77 (abstract no THB82)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
6
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Each patient must have an identical twin in a normal state of health with a normal screening lab panel and a normal immune profile who is documented to be antibody and culture and polymerase chain reaction (PCR) negative for HIV.
  • Ability to provide informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancy other than Kaposi's sarcoma.

Patients with the following are excluded:

  • Unwillingness to comply with current NIH Clinical Center guidelines concerning appropriate notification of all current sexual partners of an individual regarding his or her positive HIV serostatus and the risk of transmission of HIV infection.
  • Presence of a serious opportunistic infection or other illness or condition that, in the opinion of the principal investigator, warrants exclusion from participation in the study.

Current use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000647
Other Study ID Numbers  ICMJE IRP 011
11723 ( Registry Identifier: DAIDS ES Registry Number )
90 I-0076
NIAID 90 CC-IRP011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: KM Zunich
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP