translation agency

Degree and duration of D4T antiviral effect in human subjects.
Smith HB; Griffith B; Kim G; Walesky M; Friedland G; Yale University,
December 30, 1995
Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16;:131.

OBJECTIVE: To assess the virologic response to D4T in HIV positive subjects treated over a 52 week period. METHOD: Subjects with CD4 less than 500 were randomly assigned to 1 of 3 dosing groups (0.1, 0.5, 2.0 mg/kg/d). HIV cultures of peripheral blood mononuclear cells (PBMCs) were performed at baseline and weeks (wks) 4, 10, 22, 34 and 52 following the ACTG consensus protocol for quantitative HIV microcultures. RESULTS: Mean CD4 of the 15 subjects at entry was 240 (median 282); 6 had CD4 less than or equal to 200. Mean duration of follow-up was 77 wks (range 40-121 wks). 11 of 15 had positive PBMC cultures at baseline; 7 have completed 52 wks of virologic monitoring; 3, 34 wks and 1, 22 wks. Serial mean and median infectious units per million PBMCs (IUPM) are shown below for those continuing on drug at each study time-point (table: see text). The drop in mean IUPM from baseline is greater than or equal to 2 logs at wks 4, 10 and 34, and greater than or equal 1 log at wks 22 and 52. The drop in median IUPM from baseline is 1-1.5 logs at wks 4, 10, and 22; 2 logs at wk 34; and 0.5 log at wk 52, 3 of the 4 subjects who had no detectable virus at baseline developed transient viremia at wks 34 or 52. Cultures in 4/5 subjects transiently off D4T returned to levels greater than or equal to baseline. In 3, viremia decreased 1-3 logs when D4T was restarted. CONCLUSIONS: Monotherapy with D4T results in a 1-2 log reduction in viremia. Ongoing viral suppression occurs through week 52.