The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
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-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.
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.
Study Design
N/A
Conditions
HIV Infections
Location
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda
Maryland
United States
20892
Status
Completed
Source
National Institutes of Health Clinical Center (CC)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00001540
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Meningitis, Viral
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
Central Nervous System Infections
Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.
Mononegavirales Infections
Infections with viruses of the order MONONEGAVIRALES. The concept includes FILOVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; and RHABDOVIRIDAE INFECTIONS.
Clinical Trials
The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological in...
The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complic...
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
Adults admitted to intensive care units are at risk for a variety of complications. One of the most frequent complications is the development of new infections. Infections due to a fungus...
Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial
The purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. Also the investigators will evaluate consequences of wound i...
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infecti...
PubMed Articles
Infections with non-tuberculous mycobacteria in HIV-infected patients.
Disseminated infections with non-tuberculous mycobacteria (NTM) are a life-threatening AIDS-defining illness. Localized infections include pulmonary and extra-pulmonary disease as well as the immune r...
Epidemiology, risk factors and clinical impact of infections by multiresistant bacteria in cirrhosis are poorly known. METHODS: Prospective evaluation in 2 series of cirrhotic patients admitted with i...
Periprosthetic joint infection: the economic impact of methicillin-resistant infections.
The orthopedic community has begun to witness a worrisome rise in the incidence of periprosthetic joint infections (PJIs) caused by resistant organisms. Besides other challenges associated with treati...
Borne identity: CT imaging of vascular infections.
Vascular infections present in a multitude of ways with computed tomography (CT) aiding in the diagnosis of many of the uncommon vascular infections, which are equally dangerous and carry severe life-...
At the beginning of the twentieth century Western Europe and the USA experienced an increasing interest in combating venereal diseases. Although infections in children with venereal diseases had been...
