Early Antiviral Therapy for Critically Ill HIV Infected Patients

HIV Infection Clinical Trial

Official title:

Early Antiretroviral Therapy for Critically Ill HIV Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455688
• Other study ID #: ARV-0112
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2011
• Last updated: April 10, 2018
• Start date: January 1, 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2018
• Source: Hospital Nossa Senhora da Conceicao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 30, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• HIV Infection
• HIV Infections

Intervention

Drug:
• early HAART
Initiation of HAART within 5 days of ICU admission
• Late HAART
Initiation of HAART after ICU discharge

Locations

Country	Name	City	State
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality	It is a estimative of length of hospital stay	4 weeks
Secondary	6-month mortality		6 months