Early Antiviral Therapy for Critically Ill HIV Infected Patients

Hospital Nossa Senhora da Conceicao

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Late HAART; Drug: early HAART

Study type: Interventional

Funder types: Other

Identifiers

NCT01455688

ARV-0112

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Early antiviral therapy

Experimental group

Treatment:

Drug: early HAART

Conventional therapy

Active Comparator group

Treatment:

Drug: Late HAART