Combination Antiretroviral Therapy with Bone Marrow and Lymphocyte Transplantation for HIV-Infected Patients
This study aims to treat HIV-infected individuals by combining antiretroviral therapy with bone marrow and lymphocyte transplantation.
CD4-IgG
+ Zidovudine
+ Interferon alfa-n1
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, United StatesOpen Natl Inst of Allergy & Infect Dis / Cln Ctr in Google Maps