Zephyr Foundation

National Institutes of Health
National Institute of Allergy and Infectious Diseases

HIV Research
National Institute of Allergy and Infectious Diseases
National Institutes of Health

Name of Study: Immunologic and Virologic Response in HIV Infected HLA-B*57 Progressors after Infusion of Lymphocytes from HIV Infected HLA-B*57 “Elite” Long-term Non-progressors.

Goal of Study:  To determine the safety and duration of survival of donor lymphocytes following infusion.

Description of Study: This research study at the NIH Clinical Center will evaluate the safety and provide preliminary information about the anti-HIV activity of an investigational therapy that involves infusing cells obtained from an HIV-infected patient who is able to control HIV replication without therapy into a patient who is unable to control HIV replication. A subset of individuals who are HLA-B*57 positive (HLA is a protein found on the surface of white cells) are able to control HIV replication to less than 50 copies/ml (non-progressor), presumably by an immune-based mechanism. Other individuals with HLA-B*57 show no evidence of control of HIV replication, and without antiretroviral therapy will develop progressive immunodeficiency and HIV-related opportunistic complications (progressor). In this exploratory study, white blood cells obtained by apheresis from HLA B*57+ long-term non-progressors will be given to HLA B*57+ progressors who have failed at least 2 standard regimens of antiretroviral therapy, have a CD4+ count under 200 cells/mm³, and a plasma HIV viral load of >10,000 copies/mL. Recipients will be monitored for side effects and to see how long the infused cells can be detected; immune and viral markers will also be followed. Two additional cell infusions can be given, with at least 3 months between infusions. The study is seeking both donors and recipients. Up to 3 donors and 3 recipients will be eligible to participate. Donors will be compensated.

Inclusion and Exclusion Criteria: Both Donors and Recipients for this protocol must be HIV infected individuals at least 18 years old, HLA-B*57 positive, and have no significant other underlying medical problems.

• Failure of at least two previous combination regimens, one containing an NNRTI and one containing a protease inhibitor
• Viral load >10,000 copies/mL and CD4+ cell count < 200 cells/mm³ on combination antiretroviral therapy
• Patients not on combination antiretroviral therapy will be eligible, but must be willing to resume therapy and to have had a viral load >10,000 copies/mL after at least 2 weeks of therapy

• Malignancy requiring systemic therapy, or chemotherapy which is toxic to the bone marrow.
• Current untreated opportunistic infection
• Pregnancy or breast feeding.
• Current or recent use of a systemic corticosteroid, immunosuppressive or cytotoxic agent, or investigational agent
• History of autoimmune vasculitis

• CD4+ cell count ≥ 400 cells/mm³ and HIV viral load < 50 copies/mL, with no recorded HIV viral load > 1,000 copies/mL.
• HIV infection for ≥ 7 years and not on antiretroviral therapy
• Minimum weight of 110 lbs

• Any history of an AIDS-defining illnesses
• Prior antiretroviral therapy other than one or two nucleotide reverse transcriptase inhibitor (NRTI) drugs; no therapy during the previous year
• Active Hepatitis B infection, active or prior Hepatitis C infection
• History of malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of cervix or colon

Person to Contact: Mr. Rocco Caldararo at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 301-402-3481.