NCT01455688

Early Antiviral Therapy for Critically Ill HIV Infected Patients

Completed Phase 4 Last updated 12 April 2018

What this trial tests

Phase 4 trial testing early HAART in HIV Infection in 115 participants. Completed in 30 June 2016.

Timeline

1 January 2012

Primary endpoint
31 December 2015

30 June 2016

Quick facts

Lead sponsor	Hospital Nossa Senhora da Conceicao
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	115
Start date	1 January 2012
Primary completion	31 December 2015
Estimated completion	30 June 2016
Sites	1 location across Brazil

Drugs / interventions tested

• early HAART — full drug profile →
• Late HAART — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Hospital Nossa Senhora da Conceicao

Who can join

18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial.
   Boniatti MM, Pellegrini JAS, Marques LS, John JF, et al · · 2020 · cited 9× · PMID 32956419 · DOI 10.1371/journal.pone.0239452