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Early Antiviral Therapy for Critically Ill HIV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01455688
Recruitment Status : Unknown
Verified September 2013 by Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao.
Recruitment status was:  Recruiting
First Posted : October 20, 2011
Last Update Posted : September 19, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: early HAART Drug: Late HAART Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Early antiviral therapy Drug: early HAART
Initiation of HAART within 5 days of ICU admission
Active Comparator: Conventional therapy Drug: Late HAART
Initiation of HAART after ICU discharge

Outcome Measures

Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: 4 weeks ]
    It is a estimative of length of hospital stay

Secondary Outcome Measures :
  1. 6-month mortality [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455688

Contact: Marcio M Boniatti, PhD 33572221 marciobt@terra.com.br

Hospital Nossa Senhora da Conceicao Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Marcio M Boniatti, PhD    33572221    marciobt@terra.com.br   
Principal Investigator: Marcio M Boniatti, PhD         
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao
More Information

Responsible Party: Marcio Manozzo Boniatti, Principal investigator, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT01455688     History of Changes
Other Study ID Numbers: ARV-0112
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao:
critically ill patients
HIV infection

Additional relevant MeSH terms:
HIV Infections
Critical Illness
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes