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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000647
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Drug: CD4-IgG
Drug: Zidovudine
Drug: Interferon alfa-n1
Procedure: Peripheral lymphocyte infusion
Procedure: Bone marrow transplant

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 6
Study Completion Date: December 1994
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000647

Locations
United States, Maryland
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: KM Zunich
  More Information

Additional Information:
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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000647     History of Changes
Other Study ID Numbers: IRP 011, 11723, 90 I-0076, NIAID 90 CC-IRP011
Study First Received: November 2, 1999
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Recombinant Proteins
IgG
Drug Evaluation
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antigens, CD4
Zidovudine
Carrier Proteins
Interferon Type I

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Zidovudine
Immunoglobulin G
CD4 Immunoadhesins
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014