Early Antiviral Therapy for Critically Ill HIV Infected Patients

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Late HAART; Drug: early HAART

• Registration Number: NCT01455688
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Study Start: 2012-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2016-06-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	Late HAART	-
Early antiviral therapy	early HAART	-

Primary Outcome Measures

Name	Time	Method
Hospital mortality	4 weeks	It is a estimative of length of hospital stay

Secondary Outcome Measures

Name	Time	Method
6-month mortality	6 months

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceicao; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil