Search / Trial NCT00001540

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

Trial Information

Current as of December 09, 2024

Completed

Keywords

Diagnostic Immune Function Immunization Immunodeficiency Quantitative

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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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