Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001089
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of HIV and Cytomegalovirus CMV in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Human Immunodeficiency Virus HIV and Cytomegalovirus CMV Viral Burden and Development of CMV End-Organ Disease A Prospective Study in HIV-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To define relationships between 1 HIV load and risk of CMV disease 2 CMV load and the risk of developing CMV disease and 3 CMV load and HIV load To establish threshold CMV and HIV load values in peripheral blood fractions that are associated with development of CMV end-organ disease To define the natural history of CMV diseases in the context of highly active antiretroviral therapy HAART
Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated These studies would also further the understanding of the natural history of CMV disease within the context of AIDS Natural history studies conducted prior to the advent of highly active antiretroviral therapy HAART ie 3-drug regimens that include HIV reverse transcriptase and protease inhibitors have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART
Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated These studies would also further the understanding of the natural history of CMV disease within the context of AIDS Natural history studies conducted prior to the advent of highly active antiretroviral therapy HAART ie 3-drug regimens that include HIV reverse transcriptase and protease inhibitors have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART
Detailed Description:
Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated These studies would also further the understanding of the natural history of CMV disease within the context of AIDS Natural history studies conducted prior to the advent of highly active antiretroviral therapy HAART ie 3-drug regimens that include HIV reverse transcriptase and protease inhibitors have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART
In this prospective observational study HIV-infected patients who are CMV-seropositive with no clinical symptoms of CMV disease at entry are followed for three years or until the diagnosis of CMV end-organ disease or death whichever comes first Clinical evaluations are performed at baseline and every 8 weeks Blood samples for virologic studies are taken every 16 weeks
In this prospective observational study HIV-infected patients who are CMV-seropositive with no clinical symptoms of CMV disease at entry are followed for three years or until the diagnosis of CMV end-organ disease or death whichever comes first Clinical evaluations are performed at baseline and every 8 weeks Blood samples for virologic studies are taken every 16 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: