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Clinical Trials/NCT01455688
NCT01455688
Completed
Phase 4

Early Antiretroviral Therapy for Critically Ill HIV Infected Patients

Hospital Nossa Senhora da Conceicao1 site in 1 country115 target enrollmentJanuary 1, 2012

Overview

Phase
Phase 4
Intervention
early HAART
Conditions
HIV Infection
Sponsor
Hospital Nossa Senhora da Conceicao
Enrollment
115
Locations
1
Primary Endpoint
Hospital mortality
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
June 30, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcio Manozzo Boniatti

Principal investigator

Hospital Nossa Senhora da Conceicao

Eligibility Criteria

Inclusion Criteria

  • HIV infection
  • CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with HBV or HCV, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness

Exclusion Criteria

  • Regular use of HAART

Arms & Interventions

Early antiviral therapy

Intervention: early HAART

Conventional therapy

Intervention: Late HAART

Outcomes

Primary Outcomes

Hospital mortality

Time Frame: 4 weeks

It is a estimative of length of hospital stay

Secondary Outcomes

  • 6-month mortality(6 months)

Study Sites (1)

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