Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000908
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to 200 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how often Pneumocystis carinii pneumonia PCP occurs in HIV-positive patients who have stopped taking medications that help prevent PCP
The risk of developing PCP may be decreased when an HIV-positive patients CD4 cell counts cells of the immune system which fight infection are more than 200 cellsmm3 This study looks at whether it is acceptable to stop PCP prevention treatment in these patients
The risk of developing PCP may be decreased when an HIV-positive patients CD4 cell counts cells of the immune system which fight infection are more than 200 cellsmm3 This study looks at whether it is acceptable to stop PCP prevention treatment in these patients
Detailed Description:
The risk of developing PCP may be decreased with treatment-induced recovery of CD4 counts to 200 cellsmm3 Few data exist to confirm or negate the continued necessity of PCP prophylaxis for such patients This study will assess the effects of discontinuing therapy
Subjects are asked to discontinue PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase greater than 200 cellsmm3 on two measurements at least 12 weeks apart They will be evaluated for symptoms and CD4 counts every 8 weeks as well as plasma for HIV-RNA every 16 weeks for 18 months Subjects whose CD4 count falls to less than 150 cellsmm3 or between 150 and 200 cellsmm3 will have the CD4 count re-evaluated immediately or within 4 weeks If the second CD4 count is less than 200 cellsmm3 for either case conventional PCP prophylaxis will be resumed and the subject will be followed on study Subjects will be followed during study by physical exams and laboratory tests at Weeks 4 8 and every 8 weeks thereafter
Subjects are asked to discontinue PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase greater than 200 cellsmm3 on two measurements at least 12 weeks apart They will be evaluated for symptoms and CD4 counts every 8 weeks as well as plasma for HIV-RNA every 16 weeks for 18 months Subjects whose CD4 count falls to less than 150 cellsmm3 or between 150 and 200 cellsmm3 will have the CD4 count re-evaluated immediately or within 4 weeks If the second CD4 count is less than 200 cellsmm3 for either case conventional PCP prophylaxis will be resumed and the subject will be followed on study Subjects will be followed during study by physical exams and laboratory tests at Weeks 4 8 and every 8 weeks thereafter
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: