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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001540
First received: April 1, 2000
Last updated: March 3, 2008
Last verified: February 1999
  Purpose

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-infected patients. This is a prospective open-label, controlled study which will enroll 39 HIV-infected patients and 13 healthy volunteers, male or female with 18 years of age and over. The HIV-infected patients will be divided into 3 groups according to their CD4 cell count: less than 200 cells/mm(3), between 200 and 500 cells/mm(3) and greater than 500 cells/mm(3). After screening and a two week pre-study evaluation, all eligible participants will receive a primary, secondary and tertiary immunization with 2 x 10(9) PFU/kg of bacteriophage phi X174 six weeks apart. Patients who present with detectable levels of viral load at entry will be offered a more effective antiviral drug regimen. Patients will have to be on a stable antiviral regimen for at least one month prior to receiving the primary immunization. Patients will return for visits 1, 2 and 4 weeks after each immunization for clinical and laboratory evaluations. The study endpoints are: safety (as measured by incidence of adverse events, CD4 cell count and HIV plasma RNA), kinetics of bacteriophage clearance following primary immunization, quantitation of bacteriophage phi X174 specific antibody titers following primary, secondary and tertiary immunizations and determination of qualitative and quantitative antibody isotype switching following secondary and tertiary immunizations.


Condition
HIV Infections

Study Type: Observational
Official Title: The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 52
Study Start Date: April 1996
Estimated Study Completion Date: March 2000
Detailed Description:

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-infected patients. This is a prospective open-label, controlled study which will enroll 39 HIV-infected patients and 13 healthy volunteers, male or female with 18 years of age and over. The HIV-infected patients will be divided into 3 groups according to their CD4 cell count: less than 200 cells/mm(3), between 200 and 500 cells/mm(3) and greater than 500 cells/mm(3). After screening and a two week pre-study evaluation, all eligible participants will receive a primary, secondary and tertiary immunization with 2 x 10(9) PFU/kg of bacteriophage phi X174 six weeks apart. Patients who present with detectable levels of viral load at entry will be offered a more effective antiviral drug regimen. Patients will have to be on a stable antiviral regimen for at least one month prior to receiving the primary immunization. Patients will return for visits 1, 2 and 4 weeks after each immunization for clinical and laboratory evaluations. The study endpoints are: safety (as measured by incidence of adverse events, CD4 cell count and HIV plasma RNA), kinetics of bacteriophage clearance following primary immunization, quantitation of bacteriophage phi X174 specific antibody titers following primary, secondary and tertiary immunizations and determination of qualitative and quantitative antibody isotype switching following secondary and tertiary immunizations.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001540

Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001540     History of Changes
Other Study ID Numbers: 960058, 96-I-0058
Study First Received: April 1, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diagnostic
Immune Function
Immunization
Immunodeficiency
Quantitative

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014