The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 9, 2002

Keywords

ClinConnect Summary

The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disease in vivo, and to assess the impact of viral load levels and therapy-induced changes in viral load levels on the response to immunization with the neo-antigen bacteriophage phi X174. Bacteriophage phi X174 immunization is a method that has been in use for more than 25 years to assess the immunity of patients with various types of primary and secondary immunodeficiencies, including 48 HIV-infec...

Gender

ALL

Eligibility criteria

• • Male or female; 18 years of age and over.
• • Women of child bearing potential must have a negative pregnancy test 2 weeks prior to immunization and must agree to use an active form of birth control during participation. Men should exercise appropriate contraceptive measures while participating on the study.
• • Ability and willingness to sign an informed consent.
• • Adequate venous access as assessed by the Principal or Associate Investigators.
• • Willingness to comply with the protocol requirements and visit schedule.
• HIV-INFECTED PATIENTS:
• • HIV seropositivity on Elisa, confirmed with Western Blot.
• • No use or a stable use of an FDA-approved antiviral drug regimen for at least one month.
• • Life expectancy greater than 6 months.
• NORMAL VOLUNTEERS:
• • Healthy (all clinical and laboratory tests should be in the normal range).
• • HIV seronegativity.
• • No signs and/or other laboratory evidence of immunodeficiency. These include a history of persistent or recurrent infections, infections with unusual organisms or autoimmunity.
• • No prior immunization with bacteriophage phi X 174.
• • No current active opportunistic infection.
• • No use of immune -based therapies or other experimental agents, corticosteroids (at doses greater than 25 mg/d of prednisone for more than 4 weeks) or any other immunosuppressive drugs within 6 months prior to enrollment.
• • No history of severe asthma defined by the need for intermittent or continuous corticosteroid therapy.