Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01837277
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2013-04-18
Brief Title:
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
Sponsor:
Fundação Bahiana de Infectologia
Organization:
Fundação Bahiana de Infectologia
Study Overview
Official Title:
Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
IDEA
Brief Summary:
The current available antiretroviral ARV agents make possible a successful treatment of virtually all HIV-infected patients but some problems related to early mortality are still of concern mainly in resources-limited settings There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment in comparison with the observed outcomes in developed countries One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count although it does not seem to be the only reason for such outcome In Brazil and other developing countries there is still a large proportion of AIDS patients who are diagnosed with AIDS or only seek health care for HIV infection late in the course of disease Dolutegravir DTG the first HIV-1 integrase inhibitor is a potent and safe ARV drug The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia and a higher increase in CD4 cells count in comparison with those in Efavirenz EFV arm The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill CD4 cells count 50 cellsmm3 patients starting ARV therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None