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Early Antiviral Therapy for Critically Ill HIV Infected Patients

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
early HAART
Late HAART
Sponsored by
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring critically ill patients, HIV infection, HAART, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Nossa Senhora da Conceicao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early antiviral therapy

Conventional therapy

Arm Description

Outcomes

Primary Outcome Measures

Hospital mortality
It is a estimative of length of hospital stay

Secondary Outcome Measures

6-month mortality

Full Information

First Posted
October 17, 2011
Last Updated
April 10, 2018
Sponsor
Hospital Nossa Senhora da Conceicao
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1. Study Identification

Unique Protocol Identification Number
NCT01455688
Brief Title
Early Antiviral Therapy for Critically Ill HIV Infected Patients
Official Title
Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nossa Senhora da Conceicao

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
critically ill patients, HIV infection, HAART, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early antiviral therapy
Arm Type
Experimental
Arm Title
Conventional therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
early HAART
Intervention Description
Initiation of HAART within 5 days of ICU admission
Intervention Type
Drug
Intervention Name(s)
Late HAART
Intervention Description
Initiation of HAART after ICU discharge
Primary Outcome Measure Information:
Title
Hospital mortality
Description
It is a estimative of length of hospital stay
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
6-month mortality
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pregnant
Facility Information:
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32956419
Citation
Boniatti MM, Pellegrini JAS, Marques LS, John JF, Marin LG, Maito LRDM, Lisboa TC, Damiani LP, Falci DR. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial. PLoS One. 2020 Sep 21;15(9):e0239452. doi: 10.1371/journal.pone.0239452. eCollection 2020.
Results Reference
derived

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Early Antiviral Therapy for Critically Ill HIV Infected Patients

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