HIV Infections Clinical Trial
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.
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; i.e., 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; i.e., 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.
;
Observational Model: Natural History
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