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Home > "T" Clinical Trials Conditions > The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo  The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 52
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960058; 96-I-0058
Study Start Date: April 4, 1996
Record last reviewed: February 8, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001540
Other Hiv Infections Studies:
1. A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
2. A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)
3. The Healthy Life Choices Project in HIV-Positive Patients
4. Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
5. The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
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