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
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|ClinicalTrials.gov Identifier: NCT00000908|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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 patient's CD4 cell counts (cells of the immune system which fight infection) are more than 200 cells/mm3. This study looks at whether it is acceptable to stop PCP prevention treatment in these patients.
|Condition or disease|
|Pneumonia, Pneumocystis Carinii HIV Infections|
The risk of developing PCP may be decreased with treatment-induced recovery of CD4 counts to > 200 cells/mm3. 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 cells/mm3 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 cells/mm3 or between 150 and 200 cells/mm3 will have the CD4 count re-evaluated immediately or within 4 weeks. If the second CD4 count is less than 200 cells/mm3 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 Type :||Observational|
|Enrollment :||250 participants|
|Observational Model:||Natural History|
|Official Title:||Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000908
|Study Chair:||Susan Koletar|
|Study Chair:||Alison Heald|
|Study Chair:||Robert Murphy|