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 - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000647

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

MedlinePlus related topics: AIDS Bone Marrow Transplantation

Drug Information available for: Zidovudine Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, 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

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

Estimated Enrollment:

6

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

KM Zunich

More Information

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

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)

Study ID Numbers:	IRP 011, 90 I-0076, NIAID 90 CC-IRP011
Study First Received:	November 2, 1999
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00000647
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

Study placed in the following topic categories:

Interferon-alpha
Interferon Type I, Recombinant
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Interferons
Zidovudine
Healthy

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
CD4 Immunoadhesins
Interferon Alfa-2a
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Enzyme Inhibitors
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009