NCT01837277

Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients

Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Fundação Bahiana de Infectologia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severely Immunocompromised HIV Patients

Interventions

Type	Name	Description
DRUG	Dolutegravir 50 mg	Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)
DRUG	Efavirenz-based regimens	Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)

Timeline

• Start date: 2017-12-15
• Primary completion: 2021-07-31
• Completion: 2021-09-30
• First posted: 2013-04-23
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

3 sites across 1 country: Brazil