This study is an unblinded, voluntary, open-label toxicity trial assessing zidovudine as a candidate for post-exposure chemoprophylaxis for health care workers sustaining occupational exposures to HIV. The 2 secondary purposes of this study are: 1) to assess the effect of zidovudine chemoprophylaxis on the temporal sequence of the appearance of markers of HIV infection should it occur in a HCW(s) taking zidovudine chemoprophylaxis; and 2) to describe the epidemiology of exposures to HIV for which zidovudine chemoprophylaxis is elected in institutions participating in this study. Zidovudine is initiated as soon as possible for exposed HCW, but no longer than 72 hours post exposure, at a does of 200mg 6 x per day for 3 days, followed by 200mg 5 x per day for 25 days; total treatment course is 28 days. Exposed health care workers are followed for a minimum of 12 months, and for up to 60 months whenever possible. Individuals are assessed for drug toxicity as well as for early signs of HIV infection. Individuals HCWs who have elected to take zidovudine have, in general, tolerated the drug well. Subjective toxicities occur in the majority of HCWs; nonetheless, symptomatology has not correlated at all with objective hematologic toxicities. No HCW has discontinued zidovudine because of laboratory toxicity, and no HCW has seroconverted after enrollment in this study.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL060032-03
Application #
3774531
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code