Ignite Creation Date:
2024-05-05 @ 11:42 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01392430
Status:
COMPLETED
Last Update Posted:
2012-05-17
First Post:
2011-07-11
Brief Title:
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients
Sponsor:
Chiang Mai University
Organization:
Chiang Mai University
Study Overview
Official Title:
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients Who Had CD4 Cell Count 200 Cellsmm3 But Undetectable Plasma HIV-1 RNA
Status:
COMPLETED
Status Verified Date:
2012-05
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 compare the incidence of opportunistic infections between HIV-infected patients who continue and discontinue primary or secondary prophylaxis for opportunistic infections in whom receiving combination antiretroviral therapy and achieve undetectable HIV-1 RNA but CD4 cell counts are less than 200 cellsmm3
Detailed Description:
Currently combination antiretroviral therapy cART has become the standard of care in the treatment of HIV infection in many parts of the world including Thailand The benefits of cART represented by an increment of CD4 cell count and a suppression of HIV viral load have been reported worldwide The National Institute of Health NIH the Centers for Disease Control and Prevention CDC and the HIV Medicine Association of the Infectious Diseases Society of America HIVMAIDSA recommended discontinuing primary and secondary prophylaxis for prevention of opportunistic infections OIs in HIV-infected adults and adolescents receiving cART when the CD4 cell count increase to a certain level for a certain period of time For instances Pneumocystis jiroveci pneumonia PCP prophylaxis can be discontinued when patients receiving HAART and CD4 200 cellsmm3 for at least 3 months for primary prophylaxis or at least 6 months for secondary prophylaxis prophylaxis for Cryptococcal meningitis disseminated penicilliosis cerebral toxoplasmosis and disseminated mycobacterium avium complex can be discontinued when patients receiving HAART and CD4 100 cellsmm3 for at least 6 months Our practices follow this guideline However recently there are new data showing that there were no cases developed PCP after primary or secondary prophylaxis discontinuation even if CD4 cell count 200 cellsmm3 Discontinuation of secondary prophylaxis resulted in reduction in pill burdens that may improve HAART adherence decrease drug-drug interactions and also prevent drug adverse events that may happen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None