GCRC 730 (aka PHA 082) has enrolled 12 subjects as of April 2000 (one 1 female, 11 males; 3 Black, 9 White). Six have very early HIV infection (2 within 60 days of previous negative serology) and 6 comparators have advanced AIDS (absolute CD4 count <50 cells/ul). All received the four drug HAART regimen of D4T, 3TC, Indinavir, and Nelfinavir. One subject has discontinued the study for personal reasons. Four have modified therapy or doses, and of these 2 are currently off all therapy but are still being monitored on study. There have been no severe adverse events, no significant progression of disease, and no deaths on the trial. All subjects have successfully undergone frequent phlebotomy and serial tissue biopsies: 11 have had serial rectal biopsies and 11 have had serial cervical lymph node excisions. These tissues have been snap frozen rather than fixed in paraffin, and are currently undergoing comprehensive immunologic and histological analysis. Patients who have interrupted therapy (because of drug intolerance or at their request) have undergone intense monitoring to explore viral rebound and host immune responses during treatment interruptions. An extension of the antiretroviral treatment phase is currently being written to explore responses to immune-based therapeutic strategies in these patients at the extremes of the HIV disease spectrum.
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