Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
Status:
Active, not recruiting
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
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 cells/mm3) patients starting ARV therapy.