ACTG 888 is a 250-subject, prospective, non-randomized study of discontinuing prophylaxis in HIV-infected subjects who have had a CD4 count < or equal to 100 cells/mm3 any time in the past and no confirmed PCP, or who have had a confirmed episode of Pneumocystis at least 6 months prior to study entry (whether or not the CD4 count was < or equal to 100 cells/mm3). Subjects will be asked to discontinue their PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase to > 200 cells/mm3 on two measurements at least 12 weeks apart. Subjects will be evaluated for symptoms and CD4 counts every 8 weeks; plasma for HIV-RNA will be collected and stored every 16 weeks until the last subject has been on study for 18 months. Subjects whose CD4 cell count has fallen to M 150 cells/mm3 will immediately have the CD4 cell count reevaluated. Subjects whose CD4 cell count has fallen to between 150 adn 200 cells/mm3 will have the CD4 cell count reevaluated within 4 weeks. If the second CD4 count is < 200 cells/mm3, for which case, conventional PCP prophylaxis will be resumed and the subject will be followed on study. Subjects with symptoms of oral thrush or unexplained fever for > or equal to 2 weeks, will resume conventional PCP prophylaxis, and will continue to be followed on study.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S3
Application #
6265138
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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