Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Patent
1994-01-31
1997-10-07
Ketter, James
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
435 6, 435912, 435 9151, 536 2372, C12Q 170, C12Q 168, C12P 1934, C07H 2104
Patent
active
056746806
ABSTRACT:
This invention relates to the prognosis of outcome of infection with the human immunodeficiency virus (HIV). In particular, the present invention concerns monitoring individuals who are at risk for developing acquired immunodeficiency syndrome (AIDS), and individuals who are undergoing therapy for AIDS. The method for estimating the risk of the onset of a clinical event associated with infection with HIV broadly comprises evaluating the rate of HIV replication in peripheral blood cells from an individual suspected of suffering from HIV infection. More particularly, the method comprises determining the level of expression of HIV messenger RNA (mRNA) in peripheral blood cells of an asymptomatic individual. High level expression of HIV mRNA indicates a high likelihood of onset of symptoms of AIDS, and low level expression or determination of no detectable expression indicates a low likelihood of onset of symptoms of AIDS. In a specific embodiment, the level of HIV-1 mRNA, specifically multiply spliced (MS) and unspliced (US) HIV mRNA, is detected in peripheral blood cells from HIV-infected individuals, and the detection of high levels of HIV mRNA is predictive of the onset of clinical symptoms associated with disease progression, including the diagnosis of AIDS, a decrease in the number of CD4+ cells to below 500 CD4+ cells per mm.sup.3, and other clinical events. According to the invention, the onset of clinical AIDS generally occurs within about 2 years of the determination of high level expression of HIV mRNA, and the onset of clinical symptoms generally does not occur for at least about 5 years after the determination of no detectable expression of HIV mRNA.
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Baltimore David
Saksela Kalle M.
Brusca John S.
Ketter James
The Rockefeller University
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